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

NCT ID: NCT00755651

Last Updated: 2008-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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

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Abnormal Uterine Bleeding

Keywords

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Menorrhagia Uterine fibroids Endometrial polyps Endometrial cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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H Pipelle

Endometrial sample obtained using the H Pipelle

Group Type EXPERIMENTAL

Endometrial biopsy

Intervention Type PROCEDURE

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Pipelle

Endometrial sample obtained with standard Pipelle

Group Type ACTIVE_COMPARATOR

Endometrial biopsy

Intervention Type PROCEDURE

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Interventions

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Endometrial biopsy

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Intervention Type PROCEDURE

Other Intervention Names

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Pipelle H Pipelle

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Failed outpatient/office hysteroscopy
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Free Hampstead NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Royal Free Hospital

Principal Investigators

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Adam Magos, BSc MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital NHS Foundation Trust

Locations

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Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Sharma M, Taylor A, di Spiezio Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A. Outpatient hysteroscopy: traditional versus the 'no-touch' technique. BJOG. 2005 Jul;112(7):963-7. doi: 10.1111/j.1471-0528.2005.00425.x.

Reference Type RESULT
PMID: 15958000 (View on PubMed)

Other Identifiers

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REC 6056

Identifier Type: -

Identifier Source: org_study_id