Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Conditions

• Biliary Stricture

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Apr 1, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Patients undergoing cholangioscopy for evaluation biliary stricture

Primary Outcome Measure

POC-CNN Model AUC [ Time Frame: Patients will be considered negative for malignancy only with 12 months of negative follow-up or definitive negative surgical histology. ]

Central Contacts

• Liz Lemke
  507-284-2511
  [email protected]

Locations (2)

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