Pap Smear Collection With the Papette Brush

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer Screening

Intervention / Treatment
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* Diagnostic Test: Papette brush collection
* Diagnostic Test: Spatula/cytology brush collection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen Adequacy | 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 | Number of subjects to experience bleeding with collection of samples during the Pap smear exam | Baseline | 
| Collection Time | The amount of time it takes to collect a sample measured in seconds | Baseline | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pap Smear Collection