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Completed

NCT Number: NCT00613925

Endometrial Biopsy Instrument Comparison Study

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University, Portland, Oregon, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Pipelle de Cornier

Device

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 names: Pipelle

Explora curette

Device

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 names: Explora

Primary outcomes

  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 outcomes

  1. Sample Adequacy

    Time frame: at time of biopsy

    adequacy of sample obtained for examination by a pathologist

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Feb 13, 2008
Registry last updated
May 12, 2014

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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