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New liver stent aims to tame deadly cirrhosis complications

NCT ID NCT06669806

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special stent called LIVERTY TIPS, placed in the liver to create a new pathway for blood flow in people with cirrhosis and high blood pressure in the liver. The goal is to see if it can keep the new channel open and reduce problems like bleeding or fluid buildup. About 166 adults with cirrhosis and related complications will be followed for 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TIPS stent graft (a mesh tube placed in the liver to create a new blood flow channel)
What this could lead to
If successful, this stent could offer a safer, more effective way to manage serious complications of cirrhosis, reducing the need for repeat procedures.
What could go wrong
This is an early-stage, single-arm study with no comparison group, so results may not be definitive. Risks include stent blockage, infection, or worsening liver function.

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

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

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 to 75 years

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: 1. The subject who is 18 years old or above but 75 years old or below; 2. The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites; 3. The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18; 4. The subject with platelet count≥ 20×10\^9 /L; 5. Subjects or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the clinical trial. Exclusion Criteria: 1. The subject who is pregnant or lactating or plan to get pregnant during the clinical trial; 2. According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics; 3. The subject who has received surgical or interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial; 4. The subject who needs to receive or have received splenectomy; 5. The subject who has received or plan to receive liver transplantation; 6. The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators; 7. The subject with extrahepatic or hepatic malignancies; 8. The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome; 9. The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract; 10. The subject with polycystic liver disease; 11. The subject with cavernous transformation of the portal vein; 12. The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria); 13. The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis); 14. The subject with coagulation disorders (INR: \>2.5); 15. The subject with a systolic pressure lower than 80 mmHg; 16. The subject with severe tricuspid regurgitation or congestive heart failure; 17. The subject with myocardial infarction within the past 3 months; 18. The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome; 19. The subject with uncontrolled systemic infection or inflammation; 20. The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis; 21. The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment; 22. The subject with the history of epilepsy or mental illness or with cognitive impairment; 23. The subject with the expected survival time of less than 1 year; 24. The subject who is otherwise determined as ineligible for participation in this Study by investigators; 25. The subject who is participating in any other unfinished drug or medical device clinical trials.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hunan Provincial People's Hospital

    RECRUITING

    Changsha, Hunan, 410005, China

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