Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Unapproved device tested in early trial

NCT ID NCT05711316

Knowledge-focused Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 6 times

Summary

This trial is testing a medical device that has not been approved or cleared by the U.S. FDA. The study is small and early-stage, focused on understanding how the device works and whether it is safe. No results are available yet, and the device is not ready for widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

177 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. The subject must voluntarily sign and date the approved Informed Consent Form (ICF) prior to the conduct of any study-specific procedures including any procedure required to determine subject eligibility (apart from those conducted as part of the subject's routine clinical management). 2. The subject must be ≥18 years of age with a life expectancy of ≥12 months to allow for adequate completion of study procedures and collection of data. 3. The subject must be willing and able to comply with protocol requirements, including all study visits and procedures. 4. The subject must have a diagnosis of portal hypertension from cirrhosis with at least one of the following indications for de novo TIPS creation including: 1. Recurrent, or Refractory Ascites (defined as ascites that cannot be mobilized or recurs after large volume paracentesis despite dietary sodium restriction and diuretic therapy) 2. Hepatic Hydrothorax 3. Esophageal Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Esophageal Variceal Bleeding, or Recurrent Esophageal Variceal Bleeding 4. Gastric Variceal Bleeding that is Endoscopically, Medically, or Balloon Tamponade-Controlled Gastric Variceal Bleeding, or Recurrent Gastric Variceal Bleeding 5. The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤18 or Child-Pugh Score of ≤12. 6. The subject must have a platelet count of ≥50,000/microliter (with correction, if needed), as determined by the most recent pre-treatment laboratory tests performed within 7 days prior to treatment (Index Procedure). Note: If multiple lab tests are performed within 7 days prior to the date of Index Procedure, the most recent results must demonstrate eligibility. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria apply: 1. The subject is pregnant. Subjects of child-bearing potential must have a negative pregnancy test (urine or serum). 2. The subject has undergone prior transcatheter procedures for the treatment of complications from portal hypertension (e.g., TIPS, surgical shunt creation, peritoneovenous shunt, retrograde transvenous obliteration (-RTO)). Note: Subjects with variceal bleeding that have undergone -RTO at least 8 weeks prior to the planned Index Procedure may be enrolled. 3. The subject has undergone prior stent or stent graft placement in the hepatic vein, portal vein and/or inferior vena cava (IVC). 4. The subject is hemodynamically unstable with uncontrolled bleeding. 5. The subject has hepatic and/or portal vein thrombosis (PVT). Note: Subjects with partial non-flow-limiting, non-malignant PVT may be enrolled. 6. The subject has undergone prior liver transplant or is a current transplant candidate that is likely to undergo liver transplant within 6 months of enrollment. 7. The subject has extrahepatic or hepatic malignancy or a history of previous hepatic malignancy, unless treated curatively ≥5 years prior to enrollment. 8. The subject has overt (West Haven Criteria Grade ≥2), controlled or uncontrolled hepatic encephalopathy. 9. The subject has any of the following medical conditions contraindicated to placement of TIPS: 1. Congestive Heart Failure or Pulmonary Edema 2. Severe Tricuspid Regurgitation 3. Elevated Right or Left Heart Pressures 4. Polycystic Liver Disease 5. Moderate or Severe Pulmonary Hypertension or Severe Hepatopulmonary Syndrome 6. Uncontrolled Systemic Infection or Sepsis 7. Unrelieved Biliary Obstruction 8. Acute Kidney Injury, Renal Failure, or Dialysis 9. Uncontrolled Blood Coagulation/Bleeding Disorder 10. The subject has a known allergy, intolerance, or condition (e.g., allergy to contrast media/narcotics/sedatives, bleeding diathesis, or severe peripheral arterial disease) that cannot be adequately pre-treated and would preclude angiography or selective catheterization. 11. The subject has a known allergy or hypersensitivity to any of the device materials including nickel-titanium (nitinol) or tantalum. 12. The subject is taking a medication or has another medical condition, which, in the opinion of the Investigator, would preclude safe treatment with the BD Liverty™ TIPS Stent Graft, may cause the subject to be non-compliant with the protocol, or may confound the data interpretation. 13. The subject is currently participating in an investigational drug or another device study that has not completed the study treatment or that clinically interferes with the study endpoints. Note: Studies requiring extended follow-up visits for products that were investigational, but have since become commercially available, are not considered investigational studies.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cirrhosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Ascites cirrhosis of liver esophageal varices with bleeding portal hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Portal hypertension TIPS

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center, Inc.

    Boston, Massachusetts, 02215, United States

  • CHU Dijon Bourgogne

    Dijon, 21079, France

  • Centre Hospitalier Regional Universitaire de Tours

    Chambray-lès-Tours, 37170, France

  • Charité-Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • Charlotte Radiology

    Charlotte, North Carolina, 28203, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Hospices Civils de Lyon

    Lyon, 69002, France

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Medical College of Wisconsin / Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Rutgers, The State University of New Jersey

    Newark, New Jersey, 07103, United States

  • Stanford University

    Palo Alto, California, 94305, United States

  • The General Hospital Corporation d/b/a Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • The Trustees of Columbia University in the City of New York

    New York, New York, 10032, United States

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • Trustees of Indiana University ("IU")/ Indiana University Health, Inc.

    Indianapolis, Indiana, 46202, United States

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • University Hospital Frankfurt

    Frankfurt, 60590, Germany

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19125, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Washington University - Mallinckrodt Institute of Radiology

    St Louis, Missouri, 63110, United States

  • Westfälische Wilhelms-Universität

    Münster, 48149, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.