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Achieving Portal Access With Scorpion Post-Approval Study (APASS)

NCT05765253 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-12-11

Study results available
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Summary

Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.

Conditions

  • Portal Hypertension
  • Liver Diseases
  • Ascites Hepatic
  • Hydrothorax
  • Vascular Diseases

Interventions

DEVICE

Scorpion Portal Vein Access Kit

Portal Vein Access with Scorpion or Scorpion X set

DEVICE

Cook Transjugular Liver Access Set

Portal Vein Access with Ring or Rosch-Uchida set

PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Argon Medical Devices

    lead INDUSTRY

Principal Investigators

  • Venkatesh P. Krishnasamy, MD · New York Presbyterian - Columbia University Medical Center

  • Danyel C Carr, MS · Argon Medical Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2023-10-16
Completion
2023-11-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05765253 on ClinicalTrials.gov