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CompletedNCT06981052EUS-AI GBDUpdated Mar 17, 2026

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 in Cholecystitis, sponsored by University of Massachusetts, Worcester. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.

Sponsored by University of Massachusetts, Worcester · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
38
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Cholecystitis

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03

In context

Cholecystitis

266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's enrollment of 38 is below the median of 200 across 90 observational studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients undergoing endoscopic ultrasound who have a gallbladder present

Inclusion criteria

  • Age ≥ 18 years old
  • Anticipation that patient may undergo endoscopic ultrasound
  • Gallbladder present

Exclusion criteria

Exclusion Criteria:

  • Cholecystectomy
  • No indication for endoscopic ultrasound
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
38 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with gallbladders undergoing AI evaluation for stent deployment
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1

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Study locations

1 site
  • UMass Chan Medical School/Umass Memorial Health Care
    Worcester, Massachusetts 01655, United States
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References and documents

Individual participant data

Plan to share: Yes — Other researchers can reach out to UMass Chan to obtain deidentified data on a case-by-case basis.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06981052
Lead sponsor
University of Massachusetts, Worcester
Responsible party
Neil Marya (Assistant Clinical Professor of Medicine, University of Massachusetts, Worcester) — Principal investigator
First posted
May 20, 2025
Start date
May 12, 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Mar 17, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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