Trial Outcomes & Findings for Pap Smear Collection With the Papette Brush (NCT NCT05034614)

Last Updated: 2023-03-01

Results Overview

Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report

Recruitment status

COMPLETED

Study phase

Target enrollment

756 participants

Primary outcome timeframe

Baseline

Results posted on

2023-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Pap Smears Using the Papette Papette brush used to collect a Pap smear sample as standard of care. Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection	Pap Smears Using the Traditional Spatula/Cytology Brush Spatula/cytology brush used to collect a Pap smear sample as standard of care. Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
Overall Study STARTED	357	399
Overall Study COMPLETED	357	399
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pap Smear Collection With the Papette Brush

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pap Smears Using the Papette n=357 Participants Papette brush used to collect a Pap smear sample as standard of care. Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection	Pap Smears Using the Traditional Spatula/Cytology Brush n=399 Participants Spatula/cytology brush used to collect a Pap smear sample as standard of care. Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection	Total n=756 Participants Total of all reporting groups
Age, Continuous	43.9 years STANDARD_DEVIATION 13.64 • n=5 Participants	46.8 years STANDARD_DEVIATION 12.34 • n=7 Participants	45.4 years STANDARD_DEVIATION 13.04 • n=5 Participants
Sex: Female, Male Female	357 Participants n=5 Participants	399 Participants n=7 Participants	756 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	17 Participants n=5 Participants	28 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Other	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized White	309 Participants n=5 Participants	334 Participants n=7 Participants	643 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	357 participants n=5 Participants	399 participants n=7 Participants	756 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report

Outcome measures

Outcome measures
Measure	Pap Smears Using the Papette n=357 Participants Papette brush used to collect a Pap smear sample as standard of care. Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection	Pap Smears Using the Traditional Spatula/Cytology Brush n=399 Participants Spatula/cytology brush used to collect a Pap smear sample as standard of care. Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
Specimen Adequacy	335 Participants	371 Participants

SECONDARY outcome

Timeframe: Baseline

Number of subjects to experience bleeding with collection of samples during the Pap smear exam

Outcome measures

Outcome measures
Measure	Pap Smears Using the Papette n=357 Participants Papette brush used to collect a Pap smear sample as standard of care. Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection	Pap Smears Using the Traditional Spatula/Cytology Brush n=399 Participants Spatula/cytology brush used to collect a Pap smear sample as standard of care. Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
Cervical Bleeding With Collection	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Data was not collected or analyzed for this outcome measure

The amount of time it takes to collect a sample measured in seconds

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Data was not collected nor analyzed

Provider-reported survey to assess patient perceived pain for Papette brush compare to spatula/cytology bush technic as more, the same, or less patient perceived pain.

Outcome measures

Outcome data not reported

Adverse Events

Pap Smears Using the Papette

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pap Smears Using the Traditional Spatula/Cytology Brush

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

Danielle J. O'Laughlin, P.A.-C., M.S.

Mayo Clinic

Phone: 507-284-5164

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place