Trial Outcomes & Findings for Endometrial Biopsy Instrument Comparison Study (NCT NCT00613925)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

2 minutes after biopsy procedure

Results posted on

2014-05-12

Participant Flow

January 2008 to August 2009; Academic outpatient OB/GYN clinic

73 women enrolled; 3 excluded (1 cervical stenosis;1 had to have another procedure; 1 biopsy not indicated)

Participant milestones

Participant milestones
Measure	Pipelle Group Women were randomized to the Pipelle for endometrial biopsy	Explora Group Women were randomized to the Explora device for endometrial biopsy
Overall Study STARTED	37	33
Overall Study COMPLETED	37	32
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pipelle Group Women were randomized to the Pipelle for endometrial biopsy	Explora Group Women were randomized to the Explora device for endometrial biopsy
Overall Study 1 did not tolerate outpatient biopsy	0	1

Baseline Characteristics

Endometrial Biopsy Instrument Comparison Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pipelle Group n=37 Participants Women were randomized to the Pipelle for endometrial biopsy	Explora Group n=33 Participants Women were randomized to the Explora device for endometrial biopsy	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=99 Participants	33 Participants n=107 Participants	70 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	45.2 years STANDARD_DEVIATION 7.3 • n=99 Participants	46.1 years STANDARD_DEVIATION 7.7 • n=107 Participants	45.7 years STANDARD_DEVIATION 7.4 • n=206 Participants
Sex: Female, Male Female	37 Participants n=99 Participants	33 Participants n=107 Participants	70 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	37 participants n=99 Participants	33 participants n=107 Participants	70 participants n=206 Participants

PRIMARY outcome

Timeframe: 2 minutes after biopsy procedure

Population: 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)

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).

Outcome measures

Outcome measures
Measure	Pipelle Group n=37 Participants Women were randomized to the Pipelle for endometrial biopsy	Explora Group n=32 Participants Women were randomized to the Explora device for endometrial biopsy
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).	62.1 mm Standard Deviation 24.1	69.1 mm Standard Deviation 28.8

SECONDARY outcome

Timeframe: at time of biopsy

adequacy of sample obtained for examination by a pathologist

Outcome measures

Outcome measures
Measure	Pipelle Group n=37 Participants Women were randomized to the Pipelle for endometrial biopsy	Explora Group n=32 Participants Women were randomized to the Explora device for endometrial biopsy
Sample Adequacy	91.2 percentage of participants	98.6 percentage of participants

Adverse Events

Pipelle Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Explora Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alison Edelman, Associate Professor

Oregon health & Science University

Phone: 503-418-2585

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place