Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endometrial Biopsy Instrument Comparison Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00613925
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Pain Device: Pipelle de Cornier Device: Explora curette Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Sample Adequacy [ Time Frame: at time of biopsy ]
    adequacy of sample obtained for examination by a pathologist


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613925


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Alison Edelman, MD MPH, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00613925    
Other Study ID Numbers: OHSU RES 4145
First Posted: February 13, 2008    Key Record Dates
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014
Last Verified: April 2014
Keywords provided by Alison Edelman, Oregon Health and Science University:
endometrial biopsy
pain management