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

Royal Free Hampstead NHS Trust180 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

180

Conditions

Abnormal Uterine Bleeding

Interventions

Endometrial biopsyPROCEDURE

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Indication to carry out diagnostic hysteroscopy * Agrees and is suitable for outpatient/office hysteroscopy Exclusion Criteria: * Failed outpatient/office hysteroscopy

Locations (1)

Royal Free Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Discomfort

Time frame: End of procedure

Secondary Outcomes

Procedure time, biopsy adequacy

Time frame: End of procedure

Data from ClinicalTrials.gov

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