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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

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

External Links

•   Mayo Clinic Clinical Trials