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Completed

NCT Number: NCT07009587

Ionizing Radiation During Endoscopic Procedures (ENDORAY Study)

The primary objective of this prospective study was to describe the evolution of dose reference levels (DRLs) in a specialized French center during endoscopic procedures involving ionizing radiation and performed without a radiology technician. The secondary objective was to assess the influence of the operator on the recorded dose for each procedure.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

About this study

This prospective study, approved by the Institutional Review Board (IRB) of the Groupement de Coopération Sanitaire Ramsay Santé (approval no. 2019-06-010), was conducted in the endoscopy unit of Jean Mermoz Hospital (Lyon, France).

To standardize practices, all operators underwent blended training (3 hours of e-learning and 3 hours of hands-on training on the Shine Enhancer system), which was completed and validated on June 25, 2018. As per guidelines, the graphic (cine) mode was never used. Only the latest fluoroscopic images were printed and archived.

The database includes all consecutive patients who underwent an endoscopic procedure between June 26, 2018, and December 31, 2021. Each report was retrospectively reviewed to confirm the therapeutic intention (intention-to-treat).

Initially, only the type of procedure and the dose-area product (DAP) were recorded. From October 7, 2019, fluoroscopy time (FT) was also systematically collected.

Six experienced endoscopists performed all procedures. The patient's position varied depending on the procedure, although most were performed in the supine position under general anesthesia. No radiologic technician was present during the procedures. The fluoroscopic system was entirely managed by the endoscopist, including all parameter adjustments (distance between patient and detector, use of pulsed vs continuous fluoroscopy, collimation, duration, etc.).

Two mobile C-arm X-ray systems were used throughout the study: Siemens Arcadis and GE OEC Fluorostar, both under-couch systems.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18 years or older, who have been informed of the research;
  • Patients who have undergone an endoscopic procedure under radiological control
  • Subjects for whom all data concerning the methods of exposure to ionizing radiation are available;

Exclusion criteria

  • Patient under legal protection, guardianship, or curatorship;
  • Patient who has indicated their opposition to the use of their medical data (by completing and returning the opposition form that will be sent to them).

Treatment and study plan

endoscopy

Procedure

endoscopic procedure

Primary outcomes

  1. dose reference level

    Time frame: Periprocedural

    Assessment of dose reference levels (DRLs) with the Dose Area Product (DAP) collected for each procedure

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

Ionizing Radiation During Endoscopic Procedures: a Single-center, Prospective Study of Dose Reference Levels.

Acronym: ENDORAY

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

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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