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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00755651
First Posted: September 19, 2008
Last Update Posted: September 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Free Hampstead NHS Trust
  Purpose
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.

Condition Intervention
Abnormal Uterine Bleeding Procedure: Endometrial biopsy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Resource links provided by NLM:


Further study details as provided by Royal Free Hampstead NHS Trust:

Primary Outcome Measures:
  • Discomfort [ Time Frame: End of procedure ]

Secondary Outcome Measures:
  • Procedure time, biopsy adequacy [ Time Frame: End of procedure ]

Enrollment: 180
Study Start Date: January 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Failed outpatient/office hysteroscopy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755651


Locations
United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Royal Free Hampstead NHS Trust
Investigators
Principal Investigator: Adam Magos, BSc MD FRCOG Royal Free Hospital NHS Foundation Trust
  More Information

Publications:
Responsible Party: Adam Magos BSc MB BS MD FRCOG, Consultant Gynaecologist, Royal Free Hospital
ClinicalTrials.gov Identifier: NCT00755651     History of Changes
Other Study ID Numbers: REC 6056
First Submitted: September 18, 2008
First Posted: September 19, 2008
Last Update Posted: September 19, 2008
Last Verified: September 2008

Keywords provided by Royal Free Hampstead NHS Trust:
Menorrhagia
Uterine fibroids
Endometrial polyps
Endometrial cancer

Additional relevant MeSH terms:
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes