Prospective Evaluation of an Endoscopic Ultrasound (EUS)-Based Artificial Intelligence to Assist in the Deployment of Lumen Apposing Metal Stents for Gallbladder Drainage

NCT06981052 | Completed

• 1 other identifier: H00020934
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholecystitis

Outcome Measures

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.

  Day 1

Study Arms (1)

Patients with gallbladders undergoing AI evaluation for stent deployment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing endoscopic ultrasound who have a gallbladder present

You may qualify if:

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

You may not qualify if:

• Cholecystectomy
• No indication for endoscopic ultrasound

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMass Chan Medical School/Umass Memorial Health Care

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Cholecystitis

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Medicine

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 20, 2025
• Study Start: May 12, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)