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SmartGlass-Guided ERCP with Cannulation of Native Papilla 1.0

NCT06683716 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2024-11-12

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • Helios Kliniken Schwerin

    lead OTHER

Principal Investigators

  • Daniel Schmitz, Dr.med. · Helios Kliniken Schwerin

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2026-06-01
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683716 on ClinicalTrials.gov