Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368596
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-11
Brief Title:
ENDS ENDometriosis FuSobacterium Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis
Sponsor:
IRCCS Sacro Cuore Don Calabria di Negrar
Organization:
IRCCS Sacro Cuore Don Calabria di Negrar
Study Overview
Official Title:
ENDS ENDometriosis FuSobacterium Unveiling the Contribution of Fusobacterium Infection to the Development of 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:
ENDS
Brief Summary:
This will be a clinical interventional longitudinal study without pharmacological interventiondevice evaluation
A control group would however be recruited for secondary objective 1 and 2
The study is classified as interventional as Fusobacterium detection is not part of the routine management of these patients from the patients point of view participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure while the endometrial biopsy will not represent an additional examination as the study will include only patients for whom this examination is expected as per normal clinical practice
A control group would however be recruited for secondary objective 1 and 2
The study is classified as interventional as Fusobacterium detection is not part of the routine management of these patients from the patients point of view participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure while the endometrial biopsy will not represent an additional examination as the study will include only patients for whom this examination is expected as per normal clinical practice
Detailed Description:
None
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