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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: April 7, 2014
Last verified: April 2014
  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 100mm Visual Analog Scale (VAS). [ Time Frame: 2 minutes after biopsy procedure ] [ Designated as safety issue: No ]
    The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0="No Pain" (furthest point to the left) to 100="Worst Pain in My Life" (furthest point to the right).


Secondary Outcome Measures:
  • Sample Adequacy [ Time Frame: at time of biopsy ] [ Designated as safety issue: No ]
    adequacy of sample obtained for examination by a pathologist


Enrollment: 73
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pipelle Group
Women were randomized to have an endometrial biopsy collected using Pipelle de Cornier instrument.
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: Explora group
Women were randomized to have an endometrial biopsy collected using Explora curette instrument.
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 Oregon Health and Science University 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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
Results First Received: June 4, 2012
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014