Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Discomfort
End of procedure
No
Adam Magos, BSc MD FRCOG
Principal Investigator
Royal Free Hospital, London
United Kingdom: National Health Service
REC 6056
NCT00755651
January 2003
May 2007
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