NCT05034614

Pap Smear Collection With the Papette Brush

Pap Smear Collection With the Papette Brush: A Pragmatic Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 756 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 21 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Cancer Screening

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Papette brush collection	Cervical cell brush that gathers collects cervical cells during Pap smear collection
DIAGNOSTIC_TEST	Spatula/cytology brush collection	Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection

Timeline

• Start date: 2021-08-18
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-09-05
• Last updated: 2023-03-01
• Results posted: 2023-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study