CholecystitisEUS-AI GBDNCT06981052
Prospective Evaluation of an Endoscopic Ultrasound (EUS)-Based Artificial Intelligence to Assist in the Deployment of Lumen Apposing Metal Stents for Gallbladder Drainage
An observational study of Cholecystitis, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Lumen apposing metal stents are now being used to help patients who suffer from cholecystitis (infection of the gallbladder), especially in cases where patients are not candidates for surgery. Lumen apposing metal stents are effective for draining the gallbladder, however, placement is technically challenging. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 31 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing endoscopic ultrasound who have a gallbladder present
Who may be able to join
- Age ≥ 18 years old
- Anticipation that patient may undergo endoscopic ultrasound
- Gallbladder present
Who cannot join
- Cholecystectomy
- No indication for endoscopic ultrasound
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School/Umass Memorial Health Care
Worcester, Massachusetts, 01655
About this study
Lumen apposing metal stents are now being used to help patients who suffer from cholecystitis (infection of the gallbladder), especially in cases where patients are not candidates for surgery. Lumen apposing metal stents are effective for draining the gallbladder, however, placement is technically challenging. Scientists have developed an artificial intelligence to aid doctors in the deployment of these stents into the gallbladder. The aim of this study is test the performance of an artificial intelligence in providing physicians accurate information for gallbladder drainage.
- Conditions
- Cholecystitis
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with gallbladders undergoing AI evaluation for stent deployment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the EUS AI system in providing a recommendation (i.e. whether it is safe or not to drain the gallbladder)
An expert endoscopist will perform the endoscopic ultrasound procedure. When the gallbladder comes into view the expert will comment as to whether they believe that the gallbladder is safe to drain. The expert will be blinded to the AI computers interpretation of the view of the gallbladder. A second observer will record what the AI recommended at the time of the blinded expert. The expert will be considered the "gold standard" and the outcome will be accuracy of the AI in mimicking the experts recommendations.
Measured: Day 1
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 start12 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Marya, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981052
- Sponsor's protocol ID
- H00020934
- Acronym
- EUS-AI GBD
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers can reach out to UMass Chan to obtain deidentified data on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of an Endoscopic Ultrasound (EUS)-Based Artificial Intelligence to Assist in the Deployment of Lumen Apposing Metal Stents for Gallbladder Drainage
- ClinicalTrials.gov ID
- NCT06981052
- Acronym / sponsor ID
- EUS-AI GBD / H00020934
- Conditions
- Cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- 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.
Lumen apposing metal stents are now being used to help patients who suffer from cholecystitis (infection of the gallbladder), especially in cases where patients are not candidates for surgery. Lumen apposing metal stents are effective for draining the gallbladder, however, placement is technically challenging. Scientists have developed an artificial intelligence to aid doctors in the deployment of these stents into the gallbladder. The aim of this study is test the performance of an artificial intelligence in providing physicians accurate information for gallbladder drainage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with gallbladders undergoing AI evaluation for stent deployment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endoscopic ultrasound who have a gallbladder present
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Anticipation that patient may undergo endoscopic ultrasound
- Gallbladder present
Key exclusion criteria (2 listed)
- Cholecystectomy
- No indication for endoscopic ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the EUS AI system in providing a recommendation (i.e. whether it is safe or not to drain the gallbladder)
Time frame: Day 1
An expert endoscopist will perform the endoscopic ultrasound procedure. When the gallbladder comes into view the expert will comment as to whether they believe that the gallbladder is safe to drain. The expert will be blinded to the AI computers interpretation of the view of the gallbladder. A second observer will record what the AI recommended at the time of the blinded expert. The expert will be considered the "gold standard" and the outcome will be accuracy of the AI in mimicking the experts recommendations.
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 17 Mar 2026.
- Individual participant dataSharing planned: Yes. Other researchers can reach out to UMass Chan to obtain deidentified data on a case-by-case basis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, run by University of Massachusetts, Worcester 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 3 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 17 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 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?
Accuracy of the EUS AI system in providing a recommendation (i.e. whether it is safe or not to drain the gallbladder) (time frame: Day 1). 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 17 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.