Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06195280
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2023-12-22
Brief Title:
SUPerficial ENDometriosis In Magnetic Resonance Imaging
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Prospective Multicenter Study Evaluating the Diagnostic Performance of the 3DT1 Sequence in Magnetic Resonance Imaging for Superficial Endometriosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
SUPENDIM
Brief Summary:
The purpose of the study is to determine the correlation between the diagnosis of Superficial endometriosis by the 3DT1 sequence on Magnetic resonance imaging and the histology obtained by laparoscopy
Detailed Description:
This is a prospective multicenter non-randomized study evaluating the diagnostic performance of Magnetic Resonance Imaging in superficial endometriosis
The duration of the patients participation in the study is a maximum of 15 months depending on the length of the screening period and the time between Magnetic Resonance Imaging and laparoscopy
After selection the investigator will check the patients eligibility and offer her the study If she accepts and signs the informed consent form the patient will have an exploratory pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes without systematic injection of contrast product
After Magnetic Resonance Imaging the patient will benefit from a laparoscopy under general anesthesia lasting an average of one hour
The duration of the patients participation in the study is a maximum of 15 months depending on the length of the screening period and the time between Magnetic Resonance Imaging and laparoscopy
After selection the investigator will check the patients eligibility and offer her the study If she accepts and signs the informed consent form the patient will have an exploratory pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes without systematic injection of contrast product
After Magnetic Resonance Imaging the patient will benefit from a laparoscopy under general anesthesia lasting an average of one hour
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