Pap Smear Collection With the Papette Brush

Mayo Clinic

Status: Completed

Conditions: Cervical Cancer Screening

Treatments: Diagnostic Test: Spatula/cytology brush collection; Diagnostic Test: Papette brush collection

Study type: Interventional

Funder types: Other

Identifiers

NCT05034614

21-006131

Details and patient eligibility

About

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

Full 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.

Enrollment: 756 patients

Sex: Female

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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756 participants in 2 patient groups

Pap smears using the Papette

Other group

Description:

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

Treatment:

Diagnostic Test: Papette brush collection

Pap smears using the traditional spatula/cytology brush

Other group

Description:

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

Treatment:

Diagnostic Test: Spatula/cytology brush collection