Pap Smear Collection With the Papette Brush

NCT05034614 | Completed Results FDA Device

• 1 other identifier: 21-006131
• Study Type: interventional
• Target: 756
• Locations: 1 country
• Sites: 1

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

Conditions

Cervical Cancer Screening

Keywords

Pap Smear Collection

Outcome Measures

Primary Outcomes (1)

• Specimen Adequacy

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

  Baseline

Secondary Outcomes (3)

• Cervical Bleeding With Collection

  Baseline

• Collection Time

  Baseline

• Perceived Pain

  Baseline

Study Arms (2)

Pap smears using the Papette

OTHER

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

Diagnostic Test: Papette brush collection

Pap smears using the traditional spatula/cytology brush

OTHER

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

Diagnostic Test: Spatula/cytology brush collection

Interventions

Papette brush collection DIAGNOSTIC_TEST

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

Pap smears using the Papette

Spatula/cytology brush collection DIAGNOSTIC_TEST

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

Pap smears using the traditional spatula/cytology brush

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Danielle J. O'Laughlin, P.A.-C., M.S.
• Organization: Mayo Clinic

OLaughlin.Danielle@mayo.edu

507-284-5164

Study Officials

• Danielle O'Laughlin, PA-C, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: August 18, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Locations

US (1)