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

Abnormal Uterine Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755651
• Other study ID #: REC 6056
• Status: Completed
• Phase: N/A
• First received: September 18, 2008
• Last updated: September 18, 2008
• Start date: January 2003
• Est. completion date: May 2007

Study information

• Verified date: September 2008
• Source: Royal Free Hampstead NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Indication to carry out diagnostic hysteroscopy

• Agrees and is suitable for outpatient/office hysteroscopy

Exclusion Criteria:

• Failed outpatient/office hysteroscopy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Uterine Hemorrhage

Intervention

Procedure:
• Endometrial biopsy
Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Free Hampstead NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort		End of procedure	No
Secondary	Procedure time, biopsy adequacy		End of procedure	No