Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2026-01-01 @ 12:01 AM
Study NCT ID:
NCT00755651
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2008-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Sponsor:
Royal Free Hampstead NHS Trust
Organization:
Study Overview
Official Title:
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Status:
COMPLETED
Status Verified Date:
2008-09
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:
The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.
Detailed Description:
We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: