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

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Cholecystitis

Study type: Observational

Funder types: Other

Identifiers

NCT06981052

H00020934

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Cholecystectomy
• No indication for endoscopic ultrasound

Trial design

125 participants in 1 patient group

Patients with gallbladders undergoing AI evaluation for stent deployment