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Completed

NCT Number: NCT00755651

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

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.

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Key information

Conditions

Abnormal Uterine Bleeding Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Hemorrhage Leiomyoma Menorrhagia Menstruation Disturbances Metrorrhagia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Hemorrhage Uterine Neoplasms

Age range

20 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Free Hospital

London, NW3 2QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Failed outpatient/office hysteroscopy

Treatment and study plan

endometrial biopsy

Procedure

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Other names: Pipelle, H Pipelle

Primary outcomes

  1. Discomfort

    Time frame: End of procedure

Secondary outcomes

  1. Procedure time, biopsy adequacy

    Time frame: End of procedure

Sponsors and collaborators

Lead sponsor

Royal Free Hampstead NHS Trust

Other

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2008
Registry last updated
Sep 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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