PainNCT00613925

Endometrial Biopsy Instrument Comparison Study

A study testing Pipelle de Cornier and Explora curette in people with Pain, run by Oregon Health and Science University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Pipelle de Cornier and Explora curette
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 2 sitesUnited States
Study dates: Jan 2008to Jan 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 13Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Oregon Health & Science University
Portland, Oregon, 97239
Portland Veterans Affairs Medical Center
Portland, Oregon, 97239

Other trials in United States

About this study

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

Read the 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.

Conditions: Pain
Being tested: Pipelle de Cornier, Explora curette
Keywords: endometrial biopsy, pain management
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pipelle de CornierDevice
Also called Pipelle
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.
Explora curetteDevice
Also called Explora
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.

Study groups in NCT00613925
Study group	Role	What they receive
Pipelle Group	Active comparator	Women were randomized to have an endometrial biopsy collected using Pipelle de Cornier instrument. Receives: Device: Pipelle de Cornier
Explora group	Active comparator	Women were randomized to have an endometrial biopsy collected using Explora curette instrument. Receives: Device: Explora curette

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
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).
Measured: 2 minutes after biopsy procedure

Secondary outcomes (1)

Sample Adequacy
adequacy of sample obtained for examination by a pathologist
Measured: at time of biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jan 2011

First posted13 Feb 2008 (estimated)
Study startJan 2008
Primary completionJan 2009
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00613925
Sponsor's protocol ID: OHSU RES 4145
Status last verified: Apr 2014
First submitted: 31 Jan 2008
Last updated: 12 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Leclair CM, Zia JK, Doom CM, Morgan TK, Edelman AB. Pain experienced using two different methods of endometrial biopsy: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):636-641. doi: 10.1097/AOG.0b013e31820ad45b.
PubMed 21343767

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Pain Experienced by Patients Undergoing Endometrial Biopsy by Pipelle and Explora Curette
ClinicalTrials.gov ID: NCT00613925
Acronym / sponsor ID: OHSU RES 4145
Conditions: Pain
Keywords: endometrial biopsy, pain management
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Study start: Jan 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2011 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Posted 12 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Pipelle Group	Active comparator	Device: Pipelle de CornierWomen were randomized to have an endometrial biopsy collected using Pipelle de Cornier instrument.
Explora group	Active comparator	Device: Explora curetteWomen were randomized to have an endometrial biopsy collected using Explora curette instrument.

Who may qualify

Ages: 18 to 85 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pipelle de CornierAlso: PipelleA 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.	Device	Pipelle Group
Explora curetteAlso: ExploraThe 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.	Device	Explora group

Primary outcome

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).

1 secondary outcome

Sample Adequacy
Time frame: at time of biopsy

Results and safety

Results posted to the registry on 12 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pipelle Group	37	37
Explora Group	33	32

Primary outcome: 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. Mean (Standard Deviation). Unit: mm

Measure	Pipelle Group n = 37	Explora Group n = 32
Value	62.1 (24.1)	69.1 (28.8)

Population analysed: To demonstrate a 20 mm difference on the 100 mm visual analog scale, sample size of 35 women in each group (80% power, 0.05 alpha, SD 30mm)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pipelle Group	0 of 37 (0%)	0 of 37 (0%)	Not reported
Explora Group	0 of 33 (0%)	0 of 33 (0%)	Not reported

Limitations and caveats (from the sponsor): Providers not blinded

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21343767Leclair CM, Zia JK, Doom CM, Morgan TK, Edelman AB. Pain experienced using two different methods of endometrial biopsy: a randomized controlled trial. Obstet Gynecol. 2011 Mar;117(3):636-641. doi: 10.1097/AOG.0b013e31820ad45b.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison Edelman, MD, MPH principal investigator

Oregon Health and Science University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pipelle de Cornier and Explora curette in people with Pain, run by Oregon Health and Science University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00613925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.