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Recruiting NCT05779436

NCT05779436 Real-Time Cholangioscopy Artificial Intelligence Evaluation of Biliary Strictures

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Clinical Trial Summary
NCT ID NCT05779436
Status Recruiting
Phase
Sponsor Mayo Clinic
Condition Biliary Stricture
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2023-04-01
Primary Completion 2027-03

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 100 participants in total. It began in 2023-04-01 with a primary completion date of 2027-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Liz Lemke

✉ lemke.elizabeth@mayo.edu

📞 507-284-2511

Principal Investigator

Vinay Chandrasekhara, MD

PRINCIPAL INVESTIGATOR

Mayo Clinic

Frequently Asked Questions

Who can join the NCT05779436 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Biliary Stricture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05779436 currently recruiting?

Yes, NCT05779436 is actively recruiting participants. Contact the research team at lemke.elizabeth@mayo.edu for enrollment information.

Where is the NCT05779436 trial being conducted?

This trial is being conducted at Worcester, United States, Rochester, United States.

Who is sponsoring the NCT05779436 clinical trial?

NCT05779436 is sponsored by Mayo Clinic. The principal investigator is Vinay Chandrasekhara, MD at Mayo Clinic. The trial plans to enroll 100 participants.

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