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

September 18, 2008 updated by: Royal Free Hampstead NHS Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Failed outpatient/office hysteroscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H Pipelle
Endometrial sample obtained using the H Pipelle
Procedure: Endometrial biopsy
Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
Other Names:
  • Pipelle
  • H Pipelle
Active Comparator: Pipelle
Endometrial sample obtained with standard Pipelle
Procedure: Endometrial biopsy
Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
Other Names:
  • Pipelle
  • H Pipelle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Discomfort
Time Frame: End of procedure
End of procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedure time, biopsy adequacy
Time Frame: End of procedure
End of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Free Hampstead NHS Trust

Investigators

  • Principal Investigator: Adam Magos, BSc MD FRCOG, Royal Free Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimate)

September 19, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC 6056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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