Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

NCT ID: NCT05779436

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Biliary Stricture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing cholangioscopy for evaluation biliary stricture

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Vinay Chandrasekhara

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vinay Chandrasekhara, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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University of Massachusetts

Worcester, Massachusetts, United States

Site Status RECRUITING

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Neil Marya

Role: primary

(508) 334-3068

Vinay Chandrasekhara, MD

Role: primary

5077742687

Related Links

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Other Identifiers

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23-000450

Identifier Type: -

Identifier Source: org_study_id

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