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

Last updated: November 15, 2024
Sponsor: Argon Medical Devices
Overall Status: Terminated

Phase

N/A

Condition

Liver Disease

Liver Disorders

Diabetes And Hypertension

Treatment

Scorpion Portal Vein Access Kit

Cook Transjugular Liver Access Set

Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Clinical Study ID

NCT05765253
SCPVA01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years of age at the time of the TIPS procedure

  2. TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/orhydrothorax

  3. Willing and able to provide written informed consent and HIPAA (Health InsurancePortability and Accountability Act) authorization

  4. Willing and able to comply with the study procedures and follow up schedule

Exclusion

Exclusion Criteria:

  1. Known active malignancy

  2. MELD score ≥ 18 at time of screening

  3. History of polycystic liver disease

  4. Active bleeding from any source

  5. Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right toleft cardiopulmonary shunt

  6. Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of themain or target portal vein on prior CT examination

  7. Active or uncontrolled hepatic encephalopathy

  8. Systemic infection/sepsis

  9. Biliary obstruction

  10. Uncorrectable coagulopathy

  11. Any diminutive or partially thrombosed right portal vein

  12. Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome)

  13. Known sensitivity to contrast or serious contrast reaction such as anaphylaxis

  14. Pregnant women or women who are planning to become pregnant

Study Design

Total Participants: 3
Treatment Group(s): 3
Primary Treatment: Scorpion Portal Vein Access Kit
Phase:
Study Start date:
July 13, 2023
Estimated Completion Date:
November 19, 2023

Connect with a study center

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • New York Presbyterian - Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • New York Presbyterian - Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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