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NCT05034614 Clinical Trial

Pap Smear Collection With the Papette Brush

Cervical Cancer Screening Clinical Trial

Official title:
Pap Smear Collection With the Papette Brush: A Pragmatic Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05034614
Other study ID # 21-006131
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 18, 2021
Est. completion date April 1, 2022

Study information
Verified date February 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 756
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 64 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Papette brush collection
Cervical cell brush that gathers collects cervical cells during Pap smear collection
• Spatula/cytology brush collection
Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Specimen Adequacy Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report Baseline
Secondary Cervical Bleeding With Collection Number of subjects to experience bleeding with collection of samples during the Pap smear exam Baseline
Secondary Collection Time The amount of time it takes to collect a sample measured in seconds Baseline
Secondary Perceived Pain 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. Baseline
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