Viewing Study NCT03906760


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Study NCT ID: NCT03906760
Status: COMPLETED
Last Update Posted: 2019-04-08
First Post: 2018-11-15
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall
Sponsor: Hospices Civils de Lyon
Organization:

Study Overview

Official Title: Bladder Endometriosis: Evaluation in MRI of the Involvement of the Posterior Inferior Wall
Status: COMPLETED
Status Verified Date: 2019-04
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: None
Brief Summary: Evaluate MRI criteria for involvement of the posterior inferior wall of the bladder in patients with endometrial bladder disease.
Detailed Description: PURPOSE: to retrospectively evaluate on MRI the local staging with assessment of ureteral orifices extension in bladder endometriosis./ MATERIALS AND METHODS: Institutional review board approval for this study was obtained and waived written informed consent. The MR images of 39 patients operated for bladder endometriosis over a 6 years period in 3 university Lyon hospitals were reviewed. Two experienced readers reported the vesical repletion volume, the largest lesion size, the location and extension of the lesion within the bladder wall, the distance between the ureteral orifices and the lesion when the vesicovaginal wall was involved, the presence of muco-sub mucosal complex edema and the association with external adenomyosis. MR images were compared with surgical and pathological findings. Efficacy parameters were calculated with 95% confidence interval (CI).

Study Oversight

Has Oversight DMC: False
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?: