Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363682
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
Interventional Reference Levels IRL in Digestive Endoscopy
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Interventional Reference Levels IRL in Digestive Endoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EndoscopX
Brief Summary:
Scopy uses X-rays and is not without risk deterministic and stochastic effects for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use its use must be reasoned with a benefitrisk balance in favour of carrying out the interventional procedure In France there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure
Main objective To define IRL interventional reference levels adapted to each type of endoscopic procedure
Secondary objectives
Application of regulatory texts
Assessment of patient radiation protection
Radiation protection assessment for workers
Main objective To define IRL interventional reference levels adapted to each type of endoscopic procedure
Secondary objectives
Application of regulatory texts
Assessment of patient radiation protection
Radiation protection assessment for workers
Detailed Description:
Prospective data collection using an e-CRF available via Easymedstat Data completed during the endoscopy procedure Completion of a questionnaire by the practitioner who performed the procedure afterwards including the scopy doses used during the procedure the type of scopy the type of intention-to-treat
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None