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NOT YET RECRUITING
NCT06683716
NA

SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0

Sponsor: Helios Kliniken Schwerin

View on ClinicalTrials.gov

Summary

The aim of this prospective randomized study is to evaluate whether telemedical assistance via SmartGlasses is equivalent to physical presence in teaching Endoscopic Retrograde Cholangiopancreaticography (ERCP) in terms of examination success and safety. Endoscopic papilla cannulation is a key skill for successful ERCP and therefore a measurable primary endpoint of the study. This can be measured as the time (in seconds/minutes) between stable visualization of the papilla and successful endoscopic cannulation of the target structure (bile duct or pancreatic duct).

Official title: Remote Assistance Via Smart Glasses Compared to In-person Assistance for Cannulation of the Native Papilla During Endoscopic Retrograde Cholangiopancreatography

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2025-01-02

Completion Date

2026-12-31

Last Updated

2024-11-12

Healthy Volunteers

No

Interventions

OTHER

Training in presence of the instructor

The instructor gives the trainee instructions for the examination while he/she is present in the examination room.

OTHER

Telemedically training by an instructor

The trainer gives instructions to the trainee through a telemedical connection to the examiner using SmartGlasses

Locations (1)

Helios Kliniken Schwerin

Schwerin, Mecklenburg-Vorpommern, Germany