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

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 18, 2008
First Posted Date  ICMJE September 19, 2008
Last Update Posted Date September 19, 2008
Study Start Date  ICMJE January 2003
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
Discomfort [ Time Frame: End of procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2008)
Procedure time, biopsy adequacy [ Time Frame: End of procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Official Title  ICMJE Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Abnormal Uterine Bleeding
Intervention  ICMJE Procedure: Endometrial biopsy
Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy
Other Names:
  • Pipelle
  • H Pipelle
Study Arms  ICMJE
  • Experimental: H Pipelle
    Endometrial sample obtained using the H Pipelle
    Intervention: Procedure: Endometrial biopsy
  • Active Comparator: Pipelle
    Endometrial sample obtained with standard Pipelle
    Intervention: Procedure: Endometrial biopsy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
180
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Failed outpatient/office hysteroscopy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00755651
Other Study ID Numbers  ICMJE REC 6056
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adam Magos BSc MB BS MD FRCOG, Consultant Gynaecologist, Royal Free Hospital
Study Sponsor  ICMJE Royal Free Hampstead NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam Magos, BSc MD FRCOG Royal Free Hospital NHS Foundation Trust
PRS Account Royal Free Hampstead NHS Trust
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP