Liver CirrhosisNCT04668664
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
An observational study of Liver Cirrhosis and Liver Diseases, run by Cook Research Incorporated at 7 sites in 3 countries.
Trial summary
The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Cirrhosis, Liver Diseases, Hypertension, Portal
- What is being tested?
- EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 5 Apr 2021to 13 Jun 2022
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cirrhosis referred for an EGD/ EUS
Who may be able to join
- Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.
- General Exclusion Criteria:
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.
- Patient is unwilling or unable to sign and date the informed consent.
- Patient is unwilling or unable to comply with the follow-up study schedule.
- Patient for whom endoscopic procedures are contraindicated
Who cannot join
None listed.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States5 sites
Brigham & Women's Hospital
Boston, Massachusetts, 02115
University of Virginia Medical Center
Charlottesville, Virginia, 22908
The University of Kansas Health System
Kansas City, Kansas, 66160
New York-Presbyterian Hospital/Weill Cornell University Medical Center
New York, New York, 10021
University of California, Irvine
Orange, California, 92868
Hong Kong1 site
Prince of Wales Hospital/Chinese University of Hong Kong
Shatin, 999077
About this study
Official title: PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.
- Conditions
- Liver Cirrhosis, Liver Diseases, Hypertension, Portal
- Being tested
- EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)
- Keywords
- Fatty Liver, portal pressure measurement, portal pressure gradient
- Medical subject headings
- Liver Cirrhosis, Liver Diseases, Hypertension, Portal, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)Device
Measuring the portal pressure gradient in patients with cirrhosis who are referred for an esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS).
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal Pressure Gradient Measurement
Number of participants that the Portal Pressure Gradient measurement was obtainable.
Measured: once the measurement is calculated (approximately 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start5 Apr 2021
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Chang, MD, FACG, FASGE, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668664
- Sponsor's protocol ID
- 16-03
- Status last verified
- Jun 2022
- First submitted
- 9 Dec 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
- ClinicalTrials.gov ID
- NCT04668664
- Acronym / sponsor ID
- 16-03
- Conditions
- Liver Cirrhosis, Liver Diseases, Hypertension, Portal
- Keywords
- Fatty Liver, portal pressure measurement, portal pressure gradient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 16 Dec 2020 (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.
The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cirrhosis referred for an EGD/ EUS
Key inclusion criteria (6 listed)
- Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.
- Patient is unwilling or unable to sign and date the informed consent.
- Patient is unwilling or unable to comply with the follow-up study schedule.
- Patient for whom endoscopic procedures are contraindicated
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)Measuring the portal pressure gradient in patients with cirrhosis who are referred for an esophagogastroduodenoscopy (EGD) and/or endoscopic ultrasound (EUS). | Device | – |
Primary outcome
Portal Pressure Gradient Measurement
Time frame: once the measurement is calculated (approximately 1 hour)
Number of participants that the Portal Pressure Gradient measurement was obtainable.
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 21 Jun 2022.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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.
Kenneth Chang, MD, FACG, FASGE principal investigator
University of California, Irvine
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Liver Diseases, run by Cook Research Incorporated at 7 sites in 3 countries.
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 6 inclusion and 0 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 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, Hong Kong. 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?
Portal Pressure Gradient Measurement (time frame: once the measurement is calculated (approximately 1 hour)). 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 21 Jun 2022.