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


N/A
20 Years
80 Years
Not Enrolling
Female
Abnormal Uterine Bleeding

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Trial Information

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


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.


Inclusion Criteria:



- Indication to carry out diagnostic hysteroscopy

- Agrees and is suitable for outpatient/office hysteroscopy

Exclusion Criteria:

- Failed outpatient/office hysteroscopy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Discomfort

Outcome Time Frame:

End of procedure

Safety Issue:

No

Principal Investigator

Adam Magos, BSc MD FRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Free Hospital, London

Authority:

United Kingdom: National Health Service

Study ID:

REC 6056

NCT ID:

NCT00755651

Start Date:

January 2003

Completion Date:

May 2007

Related Keywords:

  • Abnormal Uterine Bleeding
  • Menorrhagia
  • Uterine fibroids
  • Endometrial polyps
  • Endometrial cancer
  • Hemorrhage
  • Uterine Hemorrhage
  • Adenoma

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