NCT07009587

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,782

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

3.6 years

First QC Date

May 16, 2025

Last Update Submit

June 3, 2025

Conditions

Gastro-Intestinal Disorder

Outcome Measures

Primary Outcomes (1)

  • dose reference level

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

    Periprocedural

Study Arms (1)

Endoscopy

Procedure: Endoscopy

Interventions

EndoscopyPROCEDURE

endoscopic procedure

Endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients participating in the study underwent a digestive endoscopy under radiological control.

You may qualify if:

  • 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;

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2025

First Posted

June 6, 2025

Study Start

June 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)