Pap Smear Collection With the Papette Brush

Not Applicable

Completed

• Conditions: Cervical Cancer Screening
• Interventions: Diagnostic Test: Spatula/cytology brush collection; Diagnostic Test: Papette brush collection

• Registration Number: NCT05034614
• Lead Sponsor: Mayo Clinic

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

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 Timeline

• Study Start: 2021-08-18
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-02
• Results First Submitted: 2023-02-02
• Results First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Results First Posted: 2023-03-01
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 756

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pap smears using the traditional spatula/cytology brush	Spatula/cytology brush collection	Spatula/cytology brush used to collect a Pap smear sample as standard of care.
Pap smears using the Papette	Papette brush collection	Papette brush used to collect a Pap smear sample as standard of care.

Primary Outcome Measures

Name	Time	Method
Specimen Adequacy	Baseline	Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report

Secondary Outcome Measures

Name	Time	Method
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.
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 measured in seconds

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States