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

This study has been completed.
Sponsor:
Information provided by:
Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:
NCT00755651
First received: September 18, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Vaginal Bleeding
U.S. FDA Resources

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

Primary Outcome Measures:
  • Discomfort [ Time Frame: End of procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedure time, biopsy adequacy [ Time Frame: End of procedure ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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, London
  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
Study First Received: September 18, 2008
Last Updated: September 18, 2008
Health Authority: United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Adenoma
Pathologic Processes
Uterine Diseases
 Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013