RecruitingNot Applicable

Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

United States100 participantsStarted 2023-04-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

POC-CNN Model AUC

Timeframe: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology.

Trial details

NCT IDNCT05779436

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03

Contact for this trial

Liz Lemke

507-284-2511 lemke.elizabeth@mayo.edu

View on ClinicalTrials.gov More Biliary Stricture trials