Achieving Portal Access With Scorpion Post-Approval Study 2

NCT ID: NCT06856655

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-03-28

Brief Summary

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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.

Detailed Description

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Conditions

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Portal Hypertension Liver Diseases Ascites Hepatic Hydrothorax Vascular Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Scorpion Portal Vein Access Kit

Procedure/Surgery: Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access

Exclusion Criteria

1. TIPS procedure was not initiated and/or no portion of the kit was introduced into the vasculature
2. Inaccessible medical records
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Argon Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SCPVA02

Identifier Type: -

Identifier Source: org_study_id

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