NCT00755651

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Royal Free Hampstead NHS Trust · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abnormal Uterine Bleeding

Interventions

Type	Name	Description
PROCEDURE	Endometrial biopsy	Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Timeline

• Start date: 2003-01-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2008-09-19
• Last updated: 2008-09-19

Locations

1 site across 1 country: United Kingdom