NCT06979622Not yet recruiting
Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS): A Prospective, Single-Arm Study
Source: ClinicalTrials.gov · Last updated 20 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Transjugular intrahepatic portosystemic shunt (TIPS) is an important method for treating complications related to portal hypertension. The difficulty of its surgical procedures lies in portal vein puncture. Improper operation may lead to complications such as hepatic artery hemorrhage, hepatic capsular hemorrhage, and biliary tract hemorrhage. At present, the means of guiding portal vein puncture are limited. There is evidence supporting that ultrasound guidance can help reduce the number of punctures and lower the radiation dose, etc. However, ordinary ultrasound is limited by the influence of dimensions and can only guide punctures in the same plane, with limited guiding value. The use of the Imedis9000 magnetic navigation system can guide percutaneous vascular puncture in multiple dimensions, which can increase the success rate of puncture and shorten the operation time. This study conducted a prospective, single-arm study. The Imedis9000 magnetic navigation system was used for real-time positioning to guide precise TIPS stent implantation. The number of punctures, puncture success rate, stent implantation success rate, and the incidence of adverse events were evaluated to determine the application value of the Imedis9000 magnetic navigation system in TIPS procedure.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 13 May 2025
- Start date
- 31 May 2025
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- High blood pressure
- NCT number
- NCT06979622
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 31 May 2025 to the primary completion date, 30 Sept 2025
- No sites listed in no 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
- Persistent severe pulmonary hypertension (mean pulmonary artery pressure \>45 mmHg) despite treatment;
- Uncontrolled systemic infection or inflammation;
- Presence of cardiac pacemaker, metallic implants, or other conditions susceptible to electromagnetic interference;
Lab values
- Severe right heart failure, congestive heart failure (ejection fraction \<40%), or severe valvular heart disease;
Other
- Hepatic encephalopathy stage III-IV;
- Pregnancy or lactation;
- Poor visualization of the portal venous system on ultrasound;
- Investigator-determined unsuitability for study participation.
Who the study is looking for
- Age≥18 years old;
- Including but not limited to patients requiring TIPS for: acute esophageal/gastric variceal bleeding, portal hypertensive gastropathy, cirrhotic ascites, cirrhotic hydrothorax, hepatorenal syndrome, Budd-Chiari syndrome, atypical portal hypertension, portal vein thrombosis, prevention of recurrent esophageal/gastric variceal bleeding, or prevention of recurrent ectopic variceal bleeding;
- Deemed by clinicians to require Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- Voluntarily signed informed consent form
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.