Early TIPS for Ascites Study

NCT ID: NCT01236339

Last Updated: 2014-06-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.

Detailed Description

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Conditions

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Liver Cirrhosis Portal Hypertension Ascites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TIPS

TIPS with GORE® VIATORR® TIPS Endoprosthesis

Group Type EXPERIMENTAL

TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis

Intervention Type DEVICE

TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis

LVP

Large Volume Paracentesis

\*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure).

Group Type ACTIVE_COMPARATOR

LVP

Intervention Type PROCEDURE

Large Volume Paracentesis

TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol

Intervention Type DEVICE

Interventions

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TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis

TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis

Intervention Type DEVICE

LVP

Large Volume Paracentesis

Intervention Type PROCEDURE

TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\> Patient has cirrhosis of the liver with portal hypertension

\> Patient has difficult to treat ascites

\> Patient is 18 years or older and \<70 years old at randomization

\> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.

\> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.

Exclusion Criteria

\> Patient has more than 6 large volume paracenteses within 90 days prior to randomization

\> Patient is contraindicated for TIPS placement

\> Patient has had previous TIPS placement
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Boyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona College of Medicine

Ziv Haskal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

University of Maryland-Baltimore

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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VTR 10-03

Identifier Type: -

Identifier Source: org_study_id

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