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NCT Number: NCT07691580

Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

Location status: Recruiting

Location contact

Benoit Dupont, MD

PRINCIPAL_INVESTIGATOR

Clara Yzet, MD

CONTACT

[email protected]

03 22 08 88 50

Henri Thiebault, MD

PRINCIPAL_INVESTIGATOR

Marion Schaefer, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

CAPTIV system

Device

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.

Primary outcomes

  1. measurement of average muscle during ERCP

    Time frame: 1 day

    measurement of average muscle during ERCP

  2. measurement of angular analysis during ERCP

    Time frame: day 1

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Clara YZET, DR

CONTACT

[email protected]

33+3 22 08 88 50

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Central Hospital, Nancy, France
  • Clinique de l'Europe, Amiens
  • Hôpital Privé Saint-Claude, Saint Quentin
  • University Hospital, Caen

Registry information

Acronym: RADIO-ERGO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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