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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06981052
Acronym
EUS-AI GBD
Enrollment
38
Registered
2025-05-20
Start date
2025-05-12
Completion date
2025-12-31
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis

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.

Interventions

None listed

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Cholecystectomy * No indication for endoscopic ultrasound

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the EUS AI system in providing a recommendation (i.e. whether it is safe or not to drain the gallbladder)Day 1An 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026