Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography (RADIO-ERGO)

July 2, 2026 updated by: Centre Hospitalier Universitaire, Amiens
A number of best practice recommendations have been developed to improve practitioner comfort, similar to those recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a chair during the procedure. The use of lead aprons is essential for certain endoscopic procedures (ERCP drainage of the bile ducts, prosthesis placement, etc.). Several retrospective studies in the surgical and radiological fields have shown an increased risk of MSDs among these populations. To distribute the weight of the apron, several shapes are available to limit stress. An apron weighs approximately 7 kg, due in particular to the amount of lead. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during ERCP.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80000
        • Recruiting
        • Centre Hospitalier Universitaire d'Amiens
        • Principal Investigator:
          • Marion Schaefer, MD
        • Contact:
        • Principal Investigator:
          • Henri Thiebault, MD
        • Principal Investigator:
          • Benoit Dupont, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult subject (age ≥ 18 years)
  • hepato-gastroenterologist
  • Performing ERCP
  • Person who has given consent for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAPTIV system
• Each practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored.
Device: CAPTIV system
Each practitioner will perform 4 ERCP recorded using the CAPTIV system. In order to know the biomechanical constraints during standard endoscopic examination (upper endoscopy and colonoscopy), an upper endoscopy and a standard colonoscopy examination will also be filmed and monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of average muscle during ERCP
Time Frame: 1 day
measurement of average muscle during ERCP
1 day
measurement of angular analysis during ERCP
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of stress during the practice of ERCP
Time Frame: day 1
level of stress during the practice of ERCP by analyzing the average data obtained from cardiofrequency monitoring
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Central Hospital, Nancy, France
University Hospital, Caen
Clinique de l'Europe, Amiens
Clinique de Saint Quentin

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 Major Dates

Study Start (Actual)

June 8, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2026_843_0024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Disorders

Clinical Trials on CAPTIV system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe