Evaluation of Biomechanical Forced During the Practice of Endoscopic Retrograde Cholangiopancreatography

NCT07691580 — Not applicable, Recruiting, 10 participants, Centre Hospitalier Universitaire, Amiens
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RegistryNCT07691580, acronym RADIO-ERGO
StatusRecruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment10 (Estimated)
SponsorCentre Hospitalier Universitaire, Amiens (Other); collaborators: Central Hospital, Nancy, France, University Hospital, Caen, Clinique de l'Europe, Amiens, Hôpital Privé Saint-Claude, Saint Quentin
ConditionsERCP, Biomechanic, Musculoskeletal Disorders
InterventionsCAPTIV system (Device)
Datesstart 2026-06-08, primary completion 2027-06-01 (estimated), completion 2027-07-01 (estimated), first posted 2026-07-09, last updated 2026-07-10
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for ERCP All trials for Biomechanic All trials of CAPTIV system

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
CAPTIV systemExperimentalDevice: 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.
  • 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.

+Outcome measures

Primary outcomes

  • measurement of average muscle during ERCP [1 day]: measurement of average muscle during ERCP
  • measurement of angular analysis during ERCP [day 1]

Secondary outcomes

  • level of stress during the practice of ERCP [day 1]: level of stress during the practice of ERCP by analyzing the average data obtained from cardiofrequency monitoring

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Centre Hospitalier Universitaire d'AmiensAmiens, PicardieFranceRecruiting