RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for Ascites

This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting.

Official registry: https://clinicaltrials.gov/study/NCT07390344 · W.L.Gore & Associates · enrollment listed as 152

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 152 people at 5 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)

Interventions: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)

Primary outcome (registry wording): Proportion of Subjects achieving primary patency through 2 years

Who it is for (from inclusion criteria)

Ages 18 Years to any
The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation
The subject has cirrhotic portal hypertension
The subject is ≥18 years of age
The subject is capable of complying with protocol requirements, including follow up

Who the registry excludes

The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis
The subject has received a liver transplantation. Patients on the transplant list are still eligible
The subject has a life expectancy of less than 6 months
The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and/or carcinoma in situ of the cervix remain eligible
The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \> 25 or Child Pugh Score of \> 14
The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor
The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation

Public study contact (from the registry)

The VIATIPS clinical study team

800-437-8181

viatips@wlgore.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

Emory University Hospital — Atlanta, Georgia (recruiting)
University of Minnesota — Minneapolis, Minnesota (recruiting)
Cleveland Clinic — Cleveland, Ohio (recruiting)
University of Texas Southwestern Medical Center — Dallas, Texas (recruiting)

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07390344 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07390344?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07390344?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary