Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Mayo Clinic

Status: Enrolling

Conditions: Biliary Stricture

Study type: Observational

Funder types: Other

Identifiers

NCT05779436

23-000450

Details and patient eligibility

About

The purpose of this study is to demonstrate the feasibility and validity of a previously developed peroral cholangioscopy (POC) convolutional neural network (CNN) to determine the etiology of biliary strictures when used in real-time.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• Anticipation that patient may undergo POC during an endoscopic retrograde cholangioscopy
• Pregnant patients can be included in the study. Use of the POC-CNN does not convey any new risk to the patient nor fetus.
• Non-English speaking subjects will be included in the study. Consent for the procedure itself is always done with the assistance of an interpreter via telephone or video. Use of the POC-CNN will be discussed with all patients via this interpreter during the procedure consent.

Exclusion criteria

• Age <18 years old
• No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP)
• Prisoner

Trial design

100 participants in 1 patient group

Patients undergoing cholangioscopy for evaluation biliary stricture