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

Royal Free Hampstead NHS Trust

Status: Completed

Conditions: Abnormal Uterine Bleeding

Treatments: Procedure: Endometrial biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT00755651

REC 6056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication to carry out diagnostic hysteroscopy
• Agrees and is suitable for outpatient/office hysteroscopy

Exclusion criteria

• Failed outpatient/office hysteroscopy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

H Pipelle

Experimental group

Description:

Endometrial sample obtained using the H Pipelle

Treatment:

Procedure: Endometrial biopsy

Pipelle

Active Comparator group

Description:

Endometrial sample obtained with standard Pipelle

Treatment:

Procedure: Endometrial biopsy