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NCT06837974Not yet recruiting

AI-guided TIPS Procedure

Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are: * Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS? * Does the AI model improve the efficacy of TIPS for participants? Participants will: * Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo) * The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded * Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
180 (estimated)
First submitted
16 Feb 2025
Start date
1 Jul 2025
Primary completion date
31 Jul 2026
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NCT number
NCT06837974

What you commit to

  • Study type: Interventional
  • Planned participants: 180
  • From 1 Jul 2025 to the primary completion date, 31 Jul 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.

Other

  • Participants are pregnant or breastfeeding.
  • Participants are unwilling or unable to sign informed consent.

Who the study is looking for

  • Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
  • Participants whose physical condition is suitable for TIPS.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wuhan Union West Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Wuhan Union Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Wuhan Union Jinyinhu Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.