Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519554
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-17
Brief Title:
Hysteroscopic Guided Endometrial Sampling Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps HYSTEROBIO
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Hysteroscopic Guided Endometrial Sampling Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps HYSTEROBIO
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
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:
HYSTEROBIO
Brief Summary:
Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated However this kind of biopsy is usually performed in many centre They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area However with 5Fr forceps biopsy are often too small to conclude
Detailed Description:
Blind biopsies using Novak or Cormier cannula had limits Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67 of cases Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies
A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific 80 versus 689 and a better positive predictive value 689 versus 437 for all kind of endometrial pathologies
A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific 80 versus 689 and a better positive predictive value 689 versus 437 for all kind of endometrial pathologies
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-A00621-52 | OTHER | IDRCB | None |