Back to resultsStudies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Primary Purpose
Abnormal Uterine Bleeding
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endometrial biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Abnormal Uterine Bleeding focused on measuring Menorrhagia, Uterine fibroids, Endometrial polyps, Endometrial cancer
Eligibility Criteria
Inclusion Criteria:
- Indication to carry out diagnostic hysteroscopy
- Agrees and is suitable for outpatient/office hysteroscopy
Exclusion Criteria:
- Failed outpatient/office hysteroscopy
Sites / Locations
- Royal Free Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
H Pipelle
Pipelle
Arm Description
Endometrial sample obtained using the H Pipelle
Endometrial sample obtained with standard Pipelle
Outcomes
Primary Outcome Measures
Discomfort
Secondary Outcome Measures
Procedure time, biopsy adequacy
Full Information
NCT ID
NCT00755651
First Posted
September 18, 2008
Last Updated
September 18, 2008
Sponsor
Royal Free Hampstead NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00755651
Brief Title
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Official Title
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Free Hampstead NHS Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding
Keywords
Menorrhagia, Uterine fibroids, Endometrial polyps, Endometrial cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
H Pipelle
Arm Type
Experimental
Arm Description
Endometrial sample obtained using the H Pipelle
Arm Title
Pipelle
Arm Type
Active Comparator
Arm Description
Endometrial sample obtained with standard Pipelle
Intervention Type
Procedure
Intervention Name(s)
Endometrial biopsy
Other Intervention Name(s)
Pipelle, H Pipelle
Intervention Description
Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
Primary Outcome Measure Information:
Title
Discomfort
Time Frame
End of procedure
Secondary Outcome Measure Information:
Title
Procedure time, biopsy adequacy
Time Frame
End of procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indication to carry out diagnostic hysteroscopy
Agrees and is suitable for outpatient/office hysteroscopy
Exclusion Criteria:
Failed outpatient/office hysteroscopy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Magos, BSc MD FRCOG
Organizational Affiliation
Royal Free Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
15958000
Citation
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.
Results Reference
result
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Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
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