RECRUITING

Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

Quick Facts

Study Start:2023-04-01

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05779436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* Age \<18 years old * No indication that cholangioscopy will be performed during endoscopic retrograde cholangiopancreatography (ERCP) * Prisoner

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Vinay Chandrasekhara, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

University of Massachusetts

Worcester, Massachusetts, 01655

United States

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Vinay Chandrasekhara, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2026-09

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Biliary Stricture