Portal HypertensionNCT06979622
Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS)
A study testing ultrasound combined with electromagnetic positioning guidance in people with Portal Hypertension, run by Nanfang Hospital, Southern Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- ultrasound combined with electromagnetic positioning guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe right heart failure, congestive heart failure (ejection fraction <40%), or severe valvular heart disease;
- Persistent severe pulmonary hypertension (mean pulmonary artery pressure >45 mmHg) despite treatment;
- Uncontrolled systemic infection or inflammation;
- Hepatic encephalopathy stage III-IV;
- Presence of cardiac pacemaker, metallic implants, or other conditions susceptible to electromagnetic interference;
- Pregnancy or lactation;
- Poor visualization of the portal venous system on ultrasound;
- Investigator-determined unsuitability for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS): A Prospective, Single-Arm Study
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.
- Conditions
- Portal Hypertension
- Being tested
- ultrasound combined with electromagnetic positioning guidance
- Keywords
- TIPS, Electromagnetic, ultrasound
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound combined with electromagnetic positioning guidanceOther
TIPS procedure under ultrasound combined with electromagnetic positioning guidance
| Study group | Role | What they receive |
|---|---|---|
| TIPS procedure under ultrasound combined with electromagnetic positioning guidance | Experimental | Not described Receives: Other: ultrasound combined with electromagnetic positioning guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of portal vein puncture
Puncture success rate = Number of successful cases/total number of cases ×100%.
Measured: During TIPS procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start31 May 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979622
- Sponsor's protocol ID
- NFEC-2025-136
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS): A Prospective, Single-Arm Study
- ClinicalTrials.gov ID
- NCT06979622
- Acronym / sponsor ID
- NFEC-2025-136
- Conditions
- Portal Hypertension
- Keywords
- TIPS, Electromagnetic, ultrasound
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 31 May 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIPS procedure under ultrasound combined with electromagnetic positioning guidance | Experimental | Other: ultrasound combined with electromagnetic positioning guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Severe right heart failure, congestive heart failure (ejection fraction <40%), or severe valvular heart disease;
- Persistent severe pulmonary hypertension (mean pulmonary artery pressure >45 mmHg) despite treatment;
- Uncontrolled systemic infection or inflammation;
- Hepatic encephalopathy stage III-IV;
- Presence of cardiac pacemaker, metallic implants, or other conditions susceptible to electromagnetic interference;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound combined with electromagnetic positioning guidanceTIPS procedure under ultrasound combined with electromagnetic positioning guidance | Other | TIPS procedure under ultrasound combined with electromagnetic positioning guidance |
Primary outcome
Success rate of portal vein puncture
Time frame: During TIPS procedure
Puncture success rate = Number of successful cases/total number of cases ×100%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound combined with electromagnetic positioning guidance in people with Portal Hypertension, run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaofeng Zhang (+8618565552050, 1282614092@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of portal vein puncture (time frame: During TIPS procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.