Portal HypertensionNCT02046473
3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
A study testing Volumetric Flow in TIPS in people with Portal Hypertension and Liver Disease, run by University of Michigan at 1 site in United States.
Trial summary
To determine if ultrasound measurements can accurately measure the blood pressure of flow across a stent that has been placed in a portal vein to reduce portal vein pressure known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension, Liver Disease
- What is being tested?
- Volumetric Flow in TIPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male and female 18 years of age and older
- Have an existing TIPS (Transjugular intrahepatic porto-systemic shunt)
- Have an ultrasound ordered by your physician to evaluate your TIPS.
- Able to read, understand and sign informed consent
Who cannot join
- Under 18 years of age
- Cannot be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
To determine if ultrasound measurements can accurately measure the blood pressure of flow across a stent that has been placed in a portal vein to reduce portal vein pressure known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.
Read the detailed description
To determine if 3D ultrasound measurements can accurately measure the pressure of blood flow across a stent that has been placed in a portal vein. This has been done in order to reduce portal vein pressure. These shunts are known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.
- Conditions
- Portal Hypertension, Liver Disease
- Being tested
- Volumetric Flow in TIPS
- Medical subject headings
- Hypertension, Portal, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric Flow in TIPSProcedure or surgery
Subjects who have a TIPS (transjugular intrahepatic portal-systemic shunt) for portal hypertension will undergo a clinical 3D ultrasound to determine if the TIPS is working properly. Additional ultrasounds will be obtained during the subject's clinically ordered ultrasound(s). These measurements will be taken by using a second ultrasound probe (plastic hand held device that is rubbed along the subject's abdomen). 15 minutes will be added to your clinically ordered exams that are completed 4 times a year.
| Study group | Role | What they receive |
|---|---|---|
| Volumetric Flow in TIPS | Other | Subjects who have TIPS (transjugular intrahepatic porto-systemic shunts) have measurements taken to determine if someone has increased blood pressure in the portal vein of the liver (portal hypertension). Subjects who have a TIPS receive clinical ultrasounds every 3 months to determine if the TIPS is working properly. Receives: Procedure: Volumetric Flow in TIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate portal blood flow within a transjugular portosystemic shunt
To determine the number of volumes to achieve a specified variance in the measurement and to determine the reproducibility of the volume flow measurements taken at multiple locations within the stent (3 locations with 3 measurements each for a total of 9 acquisitions).
The physicians will measure volume flow rate three times at three different locations in the shunt (that being proximal, medial and distal) to determine the reproducibility of the flow estimate.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionApr 2015
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 University of MichiganThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Novelli M.D., University of Michigan
- Investigators
- Paula Novelli, M.D., Principal investigator, University of Michigan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046473
- Sponsor's protocol ID
- HUM00054436
- Status last verified
- Nov 2016
- First submitted
- 23 Jan 2014
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Sonographic Measurement of Volumetric Flow in Transjugular Intrahepatic Porto-Systemic Shunts
- ClinicalTrials.gov ID
- NCT02046473
- Acronym / sponsor ID
- HUM00054436
- Conditions
- Portal Hypertension, Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Jan 2014 (estimated)
- 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.
To determine if ultrasound measurements can accurately measure the blood pressure of flow across a stent that has been placed in a portal vein to reduce portal vein pressure known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.
Detailed description
To determine if 3D ultrasound measurements can accurately measure the pressure of blood flow across a stent that has been placed in a portal vein. This has been done in order to reduce portal vein pressure. These shunts are known as Transjugular Intrahepatic Porto-Systemic shunts or TIPS.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volumetric Flow in TIPS | Other | Procedure: Volumetric Flow in TIPSSubjects who have TIPS (transjugular intrahepatic porto-systemic shunts) have measurements taken to determine if someone has increased blood pressure in the portal vein of the liver (portal hypertension). Subjects who have a TIPS receive clinical ultrasounds every 3 months to determine if the TIPS is working properly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female 18 years of age and older
- Have an existing TIPS (Transjugular intrahepatic porto-systemic shunt)
- Have an ultrasound ordered by your physician to evaluate your TIPS.
- Able to read, understand and sign informed consent
Key exclusion criteria (2 listed)
- Under 18 years of age
- Cannot be pregnant
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 |
|---|---|---|
| Volumetric Flow in TIPSSubjects who have a TIPS (transjugular intrahepatic portal-systemic shunt) for portal hypertension will undergo a clinical 3D ultrasound to determine if the TIPS is working properly. Additional ultrasounds will be obtained during the subject's clinically ordered ultrasound(s). These measurements will be taken by using a second ultrasound probe (plastic hand held device that is rubbed along the subject's abdomen). 15 minutes will be added to your clinically ordered exams that are completed 4 times a year. | Procedure or surgery | Volumetric Flow in TIPS |
Primary outcome
Estimate portal blood flow within a transjugular portosystemic shunt
Time frame: 4 years
To determine the number of volumes to achieve a specified variance in the measurement and to determine the reproducibility of the volume flow measurements taken at multiple locations within the stent (3 locations with 3 measurements each for a total of 9 acquisitions). The physicians will measure volume flow rate three times at three different locations in the shunt (that being proximal, medial and distal) to determine the reproducibility of the flow estimate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Paula Novelli, M.D. principal investigator
University of Michigan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volumetric Flow in TIPS in people with Portal Hypertension and Liver Disease, run by University of Michigan at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 10 Nov 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate portal blood flow within a transjugular portosystemic shunt (time frame: 4 years). 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 10 Nov 2016.