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Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Abnormal Uterine Bleeding Clinical Trial

Official title:
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00755651
Study type Interventional
Source Royal Free Hampstead NHS Trust
Contact
Status Completed
Phase N/A
Start date January 2003
Completion date May 2007
View Details
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