Pap Smear Collection With the Papette Brush

February 2, 2023 updated by: Danielle J. O'Laughlin, Mayo Clinic

Pap Smear Collection With the Papette Brush: A Pragmatic Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

756

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pap smears using the Papette
Papette brush used to collect a Pap smear sample as standard of care.
Diagnostic test: Papette brush collection
Cervical cell brush that gathers collects cervical cells during Pap smear collection
Other: Pap smears using the traditional spatula/cytology brush
Spatula/cytology brush used to collect a Pap smear sample as standard of care.
Diagnostic test: Spatula/cytology brush collection
Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen Adequacy
Time Frame: Baseline
Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical Bleeding With Collection
Time Frame: Baseline
Number of subjects to experience bleeding with collection of samples during the Pap smear exam
Baseline
Collection Time
Time Frame: Baseline
The amount of time it takes to collect a sample measured in seconds
Baseline
Perceived Pain
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Danielle O'Laughlin, PA-C, MS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-006131

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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