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

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ClinicalTrials.gov Identifier: NCT00755651
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust

Brief Summary:
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 or disease Intervention/treatment Phase
Abnormal Uterine Bleeding Procedure: Endometrial biopsy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 180 participants
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
Study Start Date : January 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

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



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

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


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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

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

Publications of Results:
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 Posted: September 19, 2008    Key Record Dates
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