Pap Smear Collection With the Papette Brush

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05034614

Collaborator

(none)

706

Enrollment

Location

Arms

11.4

Anticipated Duration (Months)

61.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research study is comparing Pap smear collection techniques using the Papette brush to traditional spatula and cytology brush for cervical cancer screening

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Screening	Diagnostic Test: Papette brush collection Diagnostic Test: Spatula/cytology brush collection	N/A

Detailed Description

At the investigators institution the investigators have been using both the traditional spatula and cytology and the Papette brush for Pap smear collection. The investigators will be comparing adequacy of sample rates, provider perceived pain and bleeding and overall satisfaction with each collection technique.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

706 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pap Smear Collection With the Papette Brush: A Pragmatic Study

Actual Study Start Date :

Aug 18, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Pap smears using the Papette Papette brush used to collect a Pap smear sample as standard of care.	Diagnostic Test: Papette brush collection Cervical cell brush that gathers collects cervical cells during Pap smear collection
Other: Pap smears using the traditional spatula/cytology brush Spatula/cytology brush used to collect a Pap smear sample as standard of care.	Diagnostic Test: Spatula/cytology brush collection Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection

Arm

Intervention/Treatment

Other: Pap smears using the Papette

Papette brush used to collect a Pap smear sample as standard of care.

Diagnostic Test: Papette brush collection

Cervical cell brush that gathers collects cervical cells during Pap smear collection

Other: Pap smears using the traditional spatula/cytology brush

Spatula/cytology brush used to collect a Pap smear sample as standard of care.

Diagnostic Test: Spatula/cytology brush collection

Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection

Outcome Measures

Primary Outcome Measures

Specimen adequacy [Baseline]
Number of samples that have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report

Secondary Outcome Measures

Cervical bleeding with collection [Baseline]
Number of subjects to experience bleeding with collection of samples during the Pap smear exam
Collection time [Baseline]
The amount of time it takes to collect a sample measure in minutes
Perceived pain [Baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult women, aged 21-64 years old.
Have given consent for medical records to be accessed.
Who will have a Pap smear exam in CIM from July 2021 through June 2022.

Exclusion Criteria:

Women, age < 21 or > 64.
Has vaginal spotting present during cervical sampling.
Did not give consent to have medical records accessed.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Danielle O'Laughlin, PA-C, MS, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Danielle J. O'Laughlin, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05034614

Other Study ID Numbers:

21-006131

First Posted:

Sep 5, 2021

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Danielle J. O'Laughlin, Principal Investigator, Mayo Clinic

Pap Smear Collection

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Oct 20, 2021