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Endometrial Biopsy Instrument Comparison Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00613925
First received: January 31, 2008
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to determine the level of pain women experience during an endometrial biopsy and the effect that the biopsy tool might have on that pain. The investigators will also evaluate the adequacy of the sample each endometrial biopsy tool collects.


Condition Intervention
Pain
 Device: Pipelle de Cornier
Device: Explora curette

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Compare Pipelle and Explora curette groups with respect to patient perception of pain associated with the procedure as rated by a 10 cm visual analog scale. [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare study groups in terms of provider's subjective sense of ease of procedure and adequacy of sample obtained for examination by a pathologist. [ Time Frame: Two Years ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: Pipelle de Cornier
A flexible suction cannula 23.5 cm in length with an inner diameter of 2.6 mm and an outer diameter of 3.1 mm. It has a 2.4mm diameter opening on the distal end, on one side of the cannula. It is a disposable polypropylene sheath with an inner plunger and is used for blind endometrial biopsy.
Other Name: Pipelle
Active Comparator: 2 Device: Explora curette
The curette has an outer diameter of 3.0 mm and is slightly more rigid. This cannula has a sharp Randall-type cutting edge on the distal end, on one side of the cannula.
Other Name: Explora

Detailed Description:

Is there a difference in pain perceived by patients undergoing endometrial biopsy via the Pipelle or Explora curette? Currently, the instrument selected for endometrial biopsy is solely dependent on provider preference. This study aims to elucidate advantages and/or disadvantages of the Pipelle versus the Explora curette in terms of pain perceived by the patient, adequacy of sample, and provider ease of use to better aid in the selection of the appropriate device.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ages 18 and over who present to the OHSU Center for Women's Health and the Portland Veteran's Affairs Medical Center with an indication for endometrial biopsy, are literate in English or Spanish, who are willing to participate in the study.

Exclusion Criteria:

  • Pregnancy, known or suspected
  • Known cervical stenosis
  • History of Mullerian tract anomalies
  • History of uterine or cervical surgery
  • Pelvic inflammatory disease (current or within the past 3 months)
  • Sexually transmitted diseases (current)
  • Puerperal or post abortion sepsis (current or within the past 3 months)
  • Purulent cervicitis (current)
  • Known clotting disorder
  • Known uterine anomalies or fibroids distorting the cavity in a way incompatible with office endometrial biopsy
  • Allergy to any component of the Pipelle or Explora curette
  • Patients who are premedicated with analgesics or misoprostol
  • Patients who require mechanical cervical dilation or receive paracervical block
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00613925

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Portland Veterans Affairs Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
  More Information

No publications provided by Oregon Health and Science University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Alison Edelman, MD MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00613925     History of Changes
Other Study ID Numbers: OHSU RES 4145
Study First Received: January 31, 2008
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
endometrial biopsy
pain management

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013