Pivotal Trial to Evaluate the Safety and Effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System (TRICAV-II)

May 19, 2026 updated by: P+F Products + Features USA Inc.

A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.

Pivotal trial to evaluate the safety and effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with severe tricuspid regurgitation and unsuitable for approved transcatheter therapies. Subjects will be followed at discharge, 1 month, 30 days, 3 months, 6 months 12 months, and annually up to 5 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
780

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Health
      • San Diego, California, United States, 92037
        • Scripps Memorial Hospital La Jolla
      • San Francisco, California, United States, 94143
        • UCSF
      • San Jose, California, United States, 94118
        • Kaiser Permanente
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center
      • Largo, Florida, United States, 33770
        • HCA Florida Largo Hospital
        • Principal Investigator:
          • Saurabh Sanon, MD
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Endeavor Health
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension Medical Group St. Vincent The Heart Center of Indiana
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • University of Kansas Medical Center
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital & Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Mid America Heart Institute
      • St Louis, Missouri, United States, 63110
        • Washington University of St Louis
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Hospital
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic
        • Principal Investigator:
          • Rishi Puri, MD
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17107
        • UPMC Pinnacle
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist
      • Houston, Texas, United States, 77030
        • University of Texas (Memorial Hermann)
      • Plano, Texas, United States, 75093
        • Baylor Scott & White Medical
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Heart Institute - Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA School of Medicine
      • Norfolk, Virginia, United States, 23507
        • Sentara Healthcare
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic
    • Washington
      • Multiple Locations, Washington, United States, 20010
        • Medstar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Eligibility Criteria for Randomized Cohort:

Inclusion Criteria:

  1. Age between 18 years and 85 years old, at the time of signing the informed consent.
  2. Severe tricuspid regurgitation (TR) and Caval Reflux (CR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. TVARC criteria will be used for the definition of TR severity.
  3. NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
  4. Adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team at the time of TR assessment for eligibility (TTE). OMT includes stable oral diuretic medications.
  5. High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.
  6. Patient is unsuitable for approved transcatheter therapies and is eligible for the TricValve procedure, based on review of screening/baseline data and imaging core lab measurements by Central Screening Committee.
  7. For females of childbearing potential, negative pregnancy test.
  8. Capable and willing to provide signed informed consent

Exclusion Criteria:

CONCOMITANT PROCEDURES

  1. Patient had a recent MI, stroke, or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.

  2. Patient requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction.

    CARDIOVASCULAR CONDITIONS

  3. LVEF ≤ 30% on echocardiography.
  4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
  5. Severe right ventricular dysfunction.
  6. Cardiac amyloidosis.
  7. Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or right heart catheterization.
  8. Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to the TricValve procedure.
  9. Hemodynamically significant pericardial effusion.
  10. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
  11. Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure).

  12. Presence of significant congenital or acquired heart disease such as RV dysplasia, arrhythmogenic RV or other conditions that could interfere with the TricValve procedure.

    ALLERGIES / INTOLERANCE

  13. Any known allergy or hypersensitivity to nitinol, bovine tissue, or contrast media that cannot be adequately treated with pre-medication.

  14. Unable to tolerate anticoagulation/antiplatelet therapy

    COMORBIDITIES

  15. Any known life-threatening condition with an estimated life span of less than 12 months.
  16. Platelet count < 75,000/mm3
  17. Child-Pugh Severity Class C (10-15 points).
  18. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.
  19. Endocarditis or active/ongoing infection requiring antibiotics.
  20. Unable to walk at least 100 meters in a 6-minute walk test.
  21. Known bleeding or clotting disorders or patient refuses blood transfusion.
  22. Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.

  23. Prior Malignancy: this study excludes participants at material risk of near-term cancer-related morbidity/mortality that could confound 12-month outcomes. This study allows the inclusion of fully treated, remote malignancies with documented No Evidence of Disease (NED)" criteria

    a. History of any malignancy within 5 years prior to randomization or any active malignancy, except: i. Adequately treated non-melanoma skin cancer (basal or squamous cell) with no evidence of disease, or ii. Carcinoma in situ (e.g., cervical, breast DCIS) treated with curative intent and no evidence of disease.

    b. Participants with a prior malignancy diagnosed >5 years before randomization are eligible if they meet all of the "No Evidence of Disease (NED)" criteria as specified below: i. No signs/symptoms of cancer on history and physical exam per standard of care; ii. No radiologic evidence of disease on surveillance imaging if such imaging is routinely indicated for that tumor type (not protocol-mandated); iii. Tumor markers (if applicable for that cancer) not suggestive of recurrence (e.g., stable/undetectable within site's lab reference and oncologist's judgment); iv. No active anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy, radiotherapy) and none planned; v. Treating oncologist's attestation (or primary physician if oncology follow-up is complete) that the participant is disease-free and appropriate for participation.

    GENERAL EXCLUSIONS

  24. Use or participation in other investigational device or drug study in which the patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.
  25. Any other condition that would preclude the ability to meet study requirements in the opinion of the investigator.
  26. Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up
  27. Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.

Eligibility Criteria for Single Arm Cohort:

Inclusion Criteria:

  1. Age > 85 years.
  2. NYHA Class III-IV, on intravenous inotropes, IABP or LVAD.
  3. LVEF ≤ 30% on echocardiography.
  4. Severe RV dysfunction.
  5. Severe pulmonary hypertension (PH), defined as Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or mean Pulmonary Artery Pressure (mPAP >35) by right heart catheterization.
  6. Renal insufficiency: eGFR between 25 and 30 mL/min/ 1.73 m² or on chronic renal replacement therapy.
  7. Patient unable to walk a minimum distance of 100 mt during 6 minute walk test.
  8. Prior malignancy not meeting the requirements applied for the Randomized Cohort, specified in Exclusion Criterion #23.
  9. Comorbidities precluding inclusion in the Randomized Cohort (exclusion criteria #15 to #24).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TricValve System + Optimal medical therapy (OMT)
Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy (OMT) in patients with caval reflux and tricuspid regurgitation.
Drug: Optimal medical therapy
Optimal medical therapy
Other Names:
  • OMT
Device: TricValve System
• Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy
Other Names:
  • Heterotopic caval valve implantation (CAVI)
Active Comparator: Optimal medical therapy (OMT) Alone
OMT alone in patients with caval reflux and tricuspid regurgitation
Drug: Optimal medical therapy
Optimal medical therapy
Other Names:
  • OMT
Experimental: TricValve Single Arm Registry
Single-Arm Registry for Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with OMT in patients with caval reflux and tricuspid regurgitation who are not eligible for randomization
Drug: Optimal medical therapy
Optimal medical therapy
Other Names:
  • OMT
Device: TricValve System
• Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy
Other Names:
  • Heterotopic caval valve implantation (CAVI)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Randomized Cohort: Caval Reflux (CR) grade reduction
Time Frame: 6 months
Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR are better.
6 months
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Time Frame: 6 months
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
6 months
Randomized Cohort: Rate of Major Adverse Events (MAE)
Time Frame: 30 days
Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT)
30 days
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv
Time Frame: 1 year
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
1 year
Registry Cohort: Rate of Major Adverse Events (MAE)
Time Frame: 30 days
Rate of Major Adverse Events (MAE) in single arm registry
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Randomized Cohort: Percentage of Device- and/or Procedure-related MAEs
Time Frame: 1 year
Rate of Major Adverse Events
1 year
Randomized Cohort: All-Cause mortality and Cardiovascular Mortality
Time Frame: 6 months and 1 year
Number of deaths from any cause as well as cardiovascular events
6 months and 1 year
Randomized Cohort: Heart Failure Hospitalizations (HFH)
Time Frame: 6 months and 1 year
Number of Heart Failure Hospitalizations and worsening HF events without hospitilization
6 months and 1 year
Randomized Cohort: RVAD Implantation or Heart Transplant
Time Frame: 6 months and 1 year
Number of patients requiring RVAD Implantation or Heart Transplant
6 months and 1 year
Randomized Cohort: Atrial Fibrillation
Time Frame: 1 year
New onset of atrial fibrillation
1 year
Randomized Cohort: Quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) .
Time Frame: 6 months and 1 year
Improvement of at least 10 points from baseline. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life (QOL)
6 months and 1 year
Randomized Cohort: Changes in symptom status New York Heart Association (NYHA class)
Time Frame: 6 months and 1 year
Reduction of at least 1 class from baseline. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
6 months and 1 year
Randomized Cohort: Changes in functional capacity (6-minute walk test, 6MWT).
Time Frame: 6 months and 1 year
Improvement of 6-minute walk distance of at least 30 meters from baseline.
6 months and 1 year
Registry Cohort: Heart Failure Hospitalization
Time Frame: 1 year
Comparison of the 12-month post-procedure HFH rate with the 12-month pre-procedure rate
1 year
Registry Cohort: Changes in Quality of life (by Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score).
Time Frame: 1 year
Change from baseline to 12 months. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life (QOL)
1 year
Roll-In Cohort: Percentage of Device- and/or Procedure-related MAEs
Time Frame: 1 year
Rate of Major Adverse Events
1 year
Roll-In Cohort: All-Cause mortality and Cardiovascular Mortality
Time Frame: 6 months and 1 year
Number of deaths from any cause as well as cardiovascular events
6 months and 1 year
Roll-In Cohort: Heart Failure Hospitalizations (HFH)
Time Frame: 6 months and 1 year
Number of Heart Failure Hospitalizations and worsening HF events without hospitalization
6 months and 1 year
Roll-In Cohort: RVAD Implantation or Heart Transplant
Time Frame: 6 months and 1 year
Number of patients requiring RVAD Implantation or Heart Transplant
6 months and 1 year
Roll-In Cohort: Atrial Fibrillation
Time Frame: 1 year
New onset of atrial fibrillation
1 year
Roll-In Cohort: Quality of life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time Frame: 6 months and 1 year
Improvement of at least 10 points from baseline. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better Quality of Life
6 months and 1 year
Roll-In Cohort: New York Heart Association (NYHA) functional class
Time Frame: 6 months and 1 year
Reduction of at least 1 class from baseline. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
6 months and 1 year
Roll-In Cohort: 6-minute walk test (6MWT).
Time Frame: 6 months and 1 year
Improvement of 6-minute walk distance of at least 30 meters from baseline.
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
P+F Products + Features USA Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Meditrial USA Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTP-TRIC-005-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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