Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
- Conditions
- Abnormal Uterine Bleeding
- Interventions
- Procedure: Endometrial biopsy
- Registration Number
- NCT00755651
- Lead Sponsor
- Royal Free Hampstead NHS Trust
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
- Indication to carry out diagnostic hysteroscopy
- Agrees and is suitable for outpatient/office hysteroscopy
- Failed outpatient/office hysteroscopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description H Pipelle Endometrial biopsy Endometrial sample obtained using the H Pipelle Pipelle Endometrial biopsy Endometrial sample obtained with standard Pipelle
- Primary Outcome Measures
Name Time Method Discomfort End of procedure
- Secondary Outcome Measures
Name Time Method Procedure time, biopsy adequacy End of procedure
Trial Locations
- Locations (1)
Royal Free Hospital
🇬🇧London, United Kingdom