Back to resultsPap Smear Collection With the Papette Brush
Primary Purpose
Cervical Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Papette brush collection
Spatula/cytology brush collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer Screening focused on measuring Pap Smear Collection
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pap smears using the Papette
Pap smears using the traditional spatula/cytology brush
Arm Description
Papette brush used to collect a Pap smear sample as standard of care.
Spatula/cytology brush used to collect a Pap smear sample as standard of care.
Outcomes
Primary Outcome Measures
Specimen Adequacy
Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report
Secondary Outcome Measures
Cervical Bleeding With Collection
Number of subjects to experience bleeding with collection of samples during the Pap smear exam
Collection Time
The amount of time it takes to collect a sample measured in seconds
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05034614
Brief Title
Pap Smear Collection With the Papette Brush
Official Title
Pap Smear Collection With the Papette Brush: A Pragmatic Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer Screening
Keywords
Pap Smear Collection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
756 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pap smears using the Papette
Arm Type
Other
Arm Description
Papette brush used to collect a Pap smear sample as standard of care.
Arm Title
Pap smears using the traditional spatula/cytology brush
Arm Type
Other
Arm Description
Spatula/cytology brush used to collect a Pap smear sample as standard of care.
Intervention Type
Diagnostic Test
Intervention Name(s)
Papette brush collection
Intervention Description
Cervical cell brush that gathers collects cervical cells during Pap smear collection
Intervention Type
Diagnostic Test
Intervention Name(s)
Spatula/cytology brush collection
Intervention Description
Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
Primary Outcome Measure Information:
Title
Specimen Adequacy
Description
Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Cervical Bleeding With Collection
Description
Number of subjects to experience bleeding with collection of samples during the Pap smear exam
Time Frame
Baseline
Title
Collection Time
Description
The amount of time it takes to collect a sample measured in seconds
Time Frame
Baseline
Title
Perceived Pain
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle O'Laughlin, PA-C, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Pap Smear Collection With the Papette Brush
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