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Clinical Trials

Our Clinical Trials Lead to Treatment Innovations

A clinical trial is a clinical research study where participants receive specific interventions —such as a drug or other therapy, a new screening test, a behavior change or procedure — under close medical monitoring and according to the research plan or protocol created by the investigators (often medical doctors). A clinical study involves research that is intended to add to medical knowledge related to the treatment, diagnosis and prevention of diseases or conditions. Without clinical trials, we would not be able to move medicine forward.

Be sure to consult with your physician before participating in a clinical trial.

Throughout our health system, researchers and medical experts are conducting a variety of clinical trials:

  • At Our Lady of the Lake Regional Medical Center in Baton Rouge, which serves as an academic medical center, clinical innovation, medical education and scientific research takes place every day. We participate in a wide range of clinical trials that are used to determine whether new drugs or treatments are both safe and effective.
  • At Our Lady of the Lake Cancer Institute, all cancer patients are evaluated for participation in a clinical trial. If you are interested in participating in one of the clinical trials offered at the Cancer Institute, or if you have questions about clinical research, please reach out to a member of our research team at (225) 765-7659 or via email research@fmolhs.org.
  • At Our Lady of the Lake Children’s Health, which is an academic teaching hospital, our patients have access to the best of the best when it comes to research and evidence-based practice initiatives. Our research team manages several research endeavors, including clinical trials, quality and safety initiatives and projects that improve patient care.
  • At St. Dominic Hospital in Jackson, Mississippi, we take pride in supporting clinical research performed at or in collaboration with St. Dominic Hospital and St. Dominic Medical Associates. St. Dominic’s Office of Research is responsible for managing and overseeing the conduct of the clinical research program. If you are a study participant or would like more information on joining a clinical trial study, a researcher and would like more information, or you would like to become a Principal Investigator, please contact us at (601) 200-6301.

Patient Information for Clinical Trials

  • What is clinical research?

    Clinical research studies are designed to answer specific medical questions. Some clinical research studies test new drugs or new combinations of drugs, new surgical procedures or devices or new ways to use existing treatments. Other research studies might involve long-term observation of patients to better understand how health or diseases progress. The goal of clinical research is to discover better ways to treat, prevent, diagnose or understand human disease.

  • Who participates in clinical trials?

    Both healthy patients and patients with an illness or disease can volunteer to be in a clinical trial. Franciscan Missionaries of Our Lady Health System offers clinical trials for adult and pediatric patients in several of the regions we serve. Patients who decide to participate in a research study usually must complete the informed consent process before they participate in the clinical trial.

    During the informed consent process, patients are provided with the information they need to make their decision about participating in a clinical trial. Members of the research team meet with the patient and provides them with an informed consent form that explains the details of the study, including the purpose, duration, required procedures, potential risks and benefits, and contact information for the research team. Patients are given time to ask questions, consult with their family, or talk to their doctors before they sign the informed consent document. Participating in a clinical trial is voluntary. Patients can refuse to participate or can withdraw from the study at any time without the loss of any medical benefit to which the patient is entitled.

  • How do I join a research study

    You can sign up for a clinical trial by:

    • Physician Referral: Ask your doctor about participating in one of our trials.
    • Phone: In the Baton Rouge area, call our clinical research department at (225) 765-7659.
    • Email: Contact our clinical research department at research@fmolhs.org.

    If you are a patient at a Franciscan Missionaries of Our Lady Health System hospital or clinic, you might be asked to participate in a research study.

  • Who funds the clinical trial?

    Clinical trials are funded by different sources, including pharmaceutical companies, device companies, the National Institutes of Health or other sponsors. FMOLHS is committed to ensuring that financial interests or other conflicts of interest do not compromise the protection of research subjects or the integrity of the research findings.

  • For more information

Clinical Trials by Specialty

  • Blood Disorders

    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • COVID-19

    Clinical Trials in the Baton Rouge area:


    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Critical Care

    Clinical Trials in the Baton Rouge area:


    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Diabetes

    Clinical Trials in the Baton Rouge area:


    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Genetic Diseases

    There are no genetic studies open at this time.

  • Cardiovascular

    Clinical Trials in the Baton Rouge area:

     

    Title: GREAT

    Purpose: This is a prospective observational cohort Registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore Endovascular Aortic products.

    Principal Investigator: Dr. Davis

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Follow-up/No longer open to enrollment

     

    Title: TGR 23-02

    Purpose: The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice.

    Principal Investigator: Dr. Davis

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open to enrollment

     

    Title: Redefine-HF

    Purpose: This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

    Principal Investigator: Dr. Moll

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open to enrollment

     

    Title: LeAPPS

    Purpose: The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

    Principal Investigator: Dr. Stelly

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open to enrollment

     

    Title: Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease (VICTORION-2-PREVENT)

    Purpose: Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

    Principle Investigator: Dr. Denzil Moraes

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Follow-up/No longer open to enrollment


    Title: AMPLATZER HUD

    Purpose: Humanitarian Device Exemption (HDE) Guidance for Healthcare Providers Requesting the AMPLATZER™ Post-Infarct Muscular VSD Occluder

    Principle Investigator: Dr. Jorge Castellanos

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment


    Title: The ENCIRCLE Trial

    Purpose: This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

    Principle Investigator: Dr. Jorge Castellanos

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment


    Title: Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study

    Purpose: Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).

    Principle Investigator: Dr. Jorge Castellanos

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment


    Title: Product Surveillance Registry (PSR)

    Purpose: The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

    Principle Investigator: Dr. Henry Patrick

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Follow-Up/No longer open to enrollment


    Title: CorMatrix Cor TRICUSPID ECM Valve Replacement Study: The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve).

    Purpose: This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.

    Principle Investigator: Dr. Terrence Stelly

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment 

     

    Title: Catalyst Trial - Study Details | Amplatzer Amulet LAAO vs. NOAC | ClinicalTrials.gov

    Purpose: A prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer™ Amulet™ device in patients with non-valvular atrial fibrillation who are at increased risk for cardioembolic events. The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

    Principle Investigator: Dr. Jorge Castellanos

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment

     

     



    Clinical Trials in the Jackson, Mississippi area:


    Title: The CORCINCH-HF Study

    Purpose: This is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System. The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).

    Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

    Principle Investigator: Dr. William Crowder

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment


    Title: Encore PFO Closure Device U.S. IDE Randomized Trial: The PerFOrm Trial

    Purpose: This is a prospective, multicenter, randomized clinical study. The Encore PFO closure device is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism.

    Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

    Principle Investigator: Dr. William Crowder

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment


    Title: Catalyst Trial - Study Details | Amplatzer Amulet LAAO vs. NOAC | ClinicalTrials.gov

    Purpose: A prospective, randomized, controlled, unblinded, multicenter clinical trial of the Amplatzer™ Amulet™ device in patients with non-valvular atrial fibrillation who are at increased risk for cardioembolic events. The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

    Study Location: Jackson Heart Clinic and St. Dominic Jackson Memorial Hospital.

    Principle Investigator: Dr. William Crowder

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment


  • Gastroenterology

    Clinical Trials in the Baton Rouge area:

    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Surgical

    Clinical Trials in the Baton Rouge area:


    Title: The Evaluation of Post-operative Pain Control with a TAP Block Using Exparel vs. Marcaine for Hernia Repairs

    Purpose: While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.

    Principle Investigator: Dr. Danielle Cobb

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment


  • Infectious Diseases

    Clinical Trials in the Baton Rouge area:


    Title: Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-resistant Mucocutaneous HSV (Herpes Simplex Virus) Infections in Immunocompromised Subjects (PRIOH-1)

    Purpose: A randomized, open label, multi-center, comparative trial, to assess the efficacy and safety of pritelivir versus foscarnet for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised adults (PRIOH-1)

    Principle Investigator: Dr. Hollis O’Neal Jr.

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment

     

    Title:Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia

    Purpose: This is a multicenter, multinational, open label single dose pharmacokinetic (PK) study enrolling at least 32 subjects. The study aims to characterize the pharmacokinetics (PK) of a single intravenous dose of CAZ AVI in pediatric subjects aged 3 months to less than 18 years who are receiving systemic antibiotic therapy for suspected or confirmed nosocomial pneumonia, including ventilator associated pneumonia.

    Principal Investigator: Dr. Michael Bolton

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open to Enrollment

    Title: Lamprene Multiple Patient Program

    Purpose: Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is no longer available through pharmacies in the US. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM). To be eligible for participation in this expanded access program, patients must have an NTM diagnosis. The treating physician has decided that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to the physician in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because the patient has a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because the patient has had side effects that prevent the use of other drugs. The physician must submit a patient registration form to initiate the patient approval process.

    Principal Investigator: Dr. Maria Reyes

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open to Enrollment

  • Neurological

    There are currently no active clinical trials. Talk with your specialist about other trial options and check here again in the future as new trials are added regularly.

  • Otolaryngology

    Clinical Trials in the Baton Rouge area:


    Title: TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality

    Purpose: The goal of this interventional study is to compare the efficacy (surgical field quality and intra-operative blood loss) or cost of TIVA alone to general inhalational anesthetics with intravenous TXA in patient participants who are undergoing endoscopic sinus surgery.

    The main questions the study aims to answer are:

    • Is the surgical field quality better when using TIVA alone compared to general inhalational anesthetics with intravenous TXA?
    • Is one method more financially advantageous to the participant and the institution compared to the other method?

    Participants will be randomized into one of the two anesthesia cohorts prior to sinus surgery. One group will be given total intravenous anesthesia (TIVA) alone and the other will be given intravenous tranexamic acid (TXA) followed by general inhalational anesthesia.

    Researchers will compare the TIVA group to the TXA group to see if one group exhibits a better surgery field viewing quality through a subjective evaluation and measurement of blood loss and also which anesthesia regimen is most cost effective upon conducting a cost analysis.

    Principle Investigator: Dr. Stephen Hernandez

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment

Oncology Clinical Trials

Pediatric Clinical Trials by Specialty

  • Blood Disorders

    There are currently no active clinical trials at this time.

  • Gastroenterology

    There are currently no active clinical trials at this time.

  • Obesity and Weight Management

    There are currently no active clinical trials at this time.

  • Infectious Diseases

    Title: The Pathogenesis of Respiratory Syncytial Virus Infection: Interactions of Immune Responses, Viral Load and Disease Severity

    Purpose: The focus of this study is to develop respiratory syncytial viral (RSV) specific immunological methodologies for use in subsequent studies, evaluating the relationship between immune pathology, viral load and disease severity of childhood RSV infection.

    Principal Investigator:Dr. Andres Carrion-Vargas, MD (OLOLCH) and Dr. Stephania Cormier, PhD (LSU A&M)

    Contact: For more information, please contact the research office at (225) 765-7659 or via email at research@fmolhs.org

    Open for Enrollment