Liver CirrhosisFLIGHTNCT07470515
Fiber-Optic Navigation During TIPS Creation: A Prospective Pilot Study
A study testing Fiber-Optic Navigation System in people with Liver Cirrhosis and Refractory Ascites, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Refractory Ascites, Variceal Bleeding
- What is being tested?
- Fiber-Optic Navigation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2027to Dec 2028
- 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
- Clinical indication for transjugular intrahepatic portosystemic shunt (TIPS) creation according to standard clinical practice (e.g., refractory ascites or variceal bleeding)
- Ability to provide written informed consent
Who cannot join
- Inability or unwillingness to provide informed consent
- Pregnancy or breastfeeding
- Absolute contraindications to TIPS according to current clinical standards (e.g., severe right heart failure, uncontrolled systemic infection)
- Participation in another clinical study that may interfere with the results of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Malik Galijasevic, MD, PhD, +4351250483248, malik.galijasevic@i-med.ac.at
Alexander Loizides, MD, Prof.
About this study
Official title: Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters
Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. A technically challenging step of the procedure is the puncture of the portal vein from the hepatic vein, which is usually performed under fluoroscopic guidance and may require multiple puncture attempts.
This prospective pilot study evaluates the use of fiber-optic navigation technology during TIPS creation. The system allows real-time three-dimensional visualization of guidewires and catheters and may improve spatial orientation during the procedure.
Read more
Approximately 30 patients with a clinical indication for TIPS placement will be included. The study will assess procedural parameters such as the number of puncture attempts, fluoroscopy time, radiation exposure, procedure duration, technical success, and complications.
The results may help to improve procedural efficiency and radiation safety during TIPS interventions.
Read the detailed description
Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension, including refractory ascites and variceal bleeding. The most technically demanding step of the procedure is the puncture of the portal vein from the hepatic vein through the liver parenchyma. This step is traditionally performed under fluoroscopic guidance and may require multiple puncture attempts, potentially leading to prolonged procedure times and increased radiation exposure.
Recent technological developments allow real-time three-dimensional visualization of guidewires and catheters using fiber-optic shape sensing technology. This approach may improve spatial orientation during complex endovascular procedures and facilitate more precise navigation within vascular structures.
The present prospective single-center pilot study aims to evaluate the feasibility and procedural impact of fiber-optic navigation during TIPS creation in routine clinical practice. Approximately 30 patients with an established clinical indication for TIPS placement will be included. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure (dose area product), total procedure time, technical success, and procedure-related complications will be prospectively recorded.
The results of this study are expected to provide initial clinical data on the integration of fiber-optic navigation into TIPS procedures and its potential impact on procedural efficiency and radiation safety.
- Being tested
- Fiber-Optic Navigation System
- Keywords
- TIPS, Portal Hypertension, Interventional Radiology, Fiber-Optic Navigation, Image-Guided Intervention, Endovascular Navigation, Radiation Reduction
- Medical subject headings
- Liver Cirrhosis, Ascites, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber-Optic Navigation SystemDevice
Use of a fiber-optic shape sensing navigation system to assist catheter and guidewire navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. The system provides real-time three-dimensional visualization of endovascular devices and is used to support portal vein access during the procedure performed according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Fiber-Optic Navigation-Assisted TIPS | Experimental | Patients undergo transjugular intrahepatic portosystemic shunt (TIPS) creation using fiber-optic navigation technology to assist catheter and guidewire navigation. The procedure is performed according to routine clinical practice at a tertiary interventional radiology center. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure, total procedure time, technical success, and procedure-related complications are prospectively recorded. Receives: Device: Fiber-Optic Navigation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of puncture attempts required to access the portal vein
Number of needle passes required to successfully puncture the portal vein during TIPS creation.
Measured: During the TIPS procedure
Secondary outcomes (5)
Fluoroscopy Time
Total fluoroscopy time recorded during the TIPS procedure.
Measured: During the procedure
Radiation Exposure
Radiation exposure measured as dose area product (DAP) during the procedure.
Measured: During the procedure
Total Procedure Time
Total duration of the TIPS procedure measured from vascular access to completion of the intervention.
Measured: During the procedure
Technical Success
Successful placement of a transjugular intrahepatic portosystemic shunt with confirmed portal-systemic flow.
Measured: End of procedure
Procedure-Related Complications
Occurrence of intra-procedural or early post-procedural complications.
Measured: Within 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective single-center pilot study evaluating fiber-optic navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. All enrolled patients undergo TIPS placement according to routine clinical practice. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure, total procedure time, technical success, and complications are prospectively recorded and analyzed.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470515
- Sponsor's protocol ID
- FLIGHT-2026
- Acronym
- FLIGHT
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 13 Mar 2026
- 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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber-Optic Navigation During Transjugular Intrahepatic Portosystemic Shunt Creation: A Prospective Pilot Study Evaluating Procedural Parameters
- ClinicalTrials.gov ID
- NCT07470515
- Acronym / sponsor ID
- FLIGHT / FLIGHT-2026
- Keywords
- TIPS, Portal Hypertension, Interventional Radiology, Fiber-Optic Navigation, Image-Guided Intervention, Endovascular Navigation, Radiation Reduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Mar 2026 (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) creation is an established minimally invasive treatment for complications of portal hypertension such as refractory ascites and variceal bleeding. A technically challenging step of the procedure is the puncture of the portal vein from the hepatic vein, which is usually performed under fluoroscopic guidance and may require multiple puncture attempts.
This prospective pilot study evaluates the use of fiber-optic navigation technology during TIPS creation. The system allows real-time three-dimensional visualization of guidewires and catheters and may improve spatial orientation during the procedure.
Approximately 30 patients with a clinical indication for TIPS placement will be included. The study will assess procedural parameters such as the number of puncture attempts, fluoroscopy time, radiation exposure, procedure duration, technical success, and complications.
The results may help to improve procedural efficiency and radiation safety during TIPS interventions.
Detailed description
Transjugular intrahepatic portosystemic shunt (TIPS) creation is an established minimally invasive treatment for complications of portal hypertension, including refractory ascites and variceal bleeding. The most technically demanding step of the procedure is the puncture of the portal vein from the hepatic vein through the liver parenchyma. This step is traditionally performed under fluoroscopic guidance and may require multiple puncture attempts, potentially leading to prolonged procedure times and increased radiation exposure.
Recent technological developments allow real-time three-dimensional visualization of guidewires and catheters using fiber-optic shape sensing technology. This approach may improve spatial orientation during complex endovascular procedures and facilitate more precise navigation within vascular structures.
The present prospective single-center pilot study aims to evaluate the feasibility and procedural impact of fiber-optic navigation during TIPS creation in routine clinical practice. Approximately 30 patients with an established clinical indication for TIPS placement will be included. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure (dose area product), total procedure time, technical success, and procedure-related complications will be prospectively recorded.
The results of this study are expected to provide initial clinical data on the integration of fiber-optic navigation into TIPS procedures and its potential impact on procedural efficiency and radiation safety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective single-center pilot study evaluating fiber-optic navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. All enrolled patients undergo TIPS placement according to routine clinical practice. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure, total procedure time, technical success, and complications are prospectively recorded and analyzed.
| Arm | Type | Receives |
|---|---|---|
| Fiber-Optic Navigation-Assisted TIPS | Experimental | Device: Fiber-Optic Navigation SystemPatients undergo transjugular intrahepatic portosystemic shunt (TIPS) creation using fiber-optic navigation technology to assist catheter and guidewire navigation. The procedure is performed according to routine clinical practice at a tertiary interventional radiology center. Procedural parameters including number of puncture attempts, fluoroscopy time, radiation exposure, total procedure time, technical success, and procedure-related complications are prospectively recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Clinical indication for transjugular intrahepatic portosystemic shunt (TIPS) creation according to standard clinical practice (e.g., refractory ascites or variceal bleeding)
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- Inability or unwillingness to provide informed consent
- Pregnancy or breastfeeding
- Absolute contraindications to TIPS according to current clinical standards (e.g., severe right heart failure, uncontrolled systemic infection)
- Participation in another clinical study that may interfere with the results of this study
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 |
|---|---|---|
| Fiber-Optic Navigation SystemUse of a fiber-optic shape sensing navigation system to assist catheter and guidewire navigation during transjugular intrahepatic portosystemic shunt (TIPS) creation. The system provides real-time three-dimensional visualization of endovascular devices and is used to support portal vein access during the procedure performed according to routine clinical practice. | Device | Fiber-Optic Navigation-Assisted TIPS |
Primary outcome
Number of puncture attempts required to access the portal vein
Time frame: During the TIPS procedure
Number of needle passes required to successfully puncture the portal vein during TIPS creation.
5 secondary outcomes
Fluoroscopy Time
Time frame: During the procedure
Radiation Exposure
Time frame: During the procedure
Total Procedure Time
Time frame: During the procedure
Technical Success
Time frame: End of procedure
Procedure-Related Complications
Time frame: Within 30 days after the procedure
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 13 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber-Optic Navigation System in people with Liver Cirrhosis and Refractory Ascites, run by Medical University Innsbruck at 1 site in Austria.
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 3 inclusion and 4 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Malik Galijasevic, MD, PhD (+4351250483248, malik.galijasevic@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture attempts required to access the portal vein (time frame: During the 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 13 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.