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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pap smears using the Papette | Other | Papette brush used to collect a Pap smear sample as standard of care. |
|
| Pap smears using the traditional spatula/cytology brush | Other | Spatula/cytology brush used to collect a Pap smear sample as standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papette brush collection | Diagnostic Test | Cervical cell brush that gathers collects cervical cells during Pap smear collection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle O'Laughlin, PA-C, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pap Smears Using the Papette | Papette brush used to collect a Pap smear sample as standard of care. Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection |
| FG001 | Pap Smears Using the Traditional Spatula/Cytology Brush | Spatula/cytology brush used to collect a Pap smear sample as standard of care. Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pap Smears Using the Papette | Papette brush used to collect a Pap smear sample as standard of care. Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection |
| BG001 | Pap Smears Using the Traditional Spatula/Cytology Brush |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Specimen Adequacy | Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report | Posted | Count of Participants | Participants | Baseline |
|
Adverse events were collected on all subjects from baseline to end of study for approximately 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pap Smears Using the Papette | Papette brush used to collect a Pap smear sample as standard of care. Papette brush collection: Cervical cell brush that gathers collects cervical cells during Pap smear collection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle J. O'Laughlin, P.A.-C., M.S. | Mayo Clinic | 507-284-5164 | OLaughlin.Danielle@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2021 | Jan 25, 2023 | Prot_SAP_000.pdf |
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| Spatula/cytology brush collection | Diagnostic Test | Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection |
|
| 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 |
Spatula/cytology brush used to collect a Pap smear sample as standard of care. Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Cervical Bleeding With Collection | Number of subjects to experience bleeding with collection of samples during the Pap smear exam | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Collection Time | The amount of time it takes to collect a sample measured in seconds | Data was not collected or analyzed for this outcome measure | Posted | 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. | Data was not collected nor analyzed | Posted | Baseline |
|
|
| 0 |
| 357 |
| 0 |
| 357 |
| 0 |
| 357 |
| EG001 | Pap Smears Using the Traditional Spatula/Cytology Brush | Spatula/cytology brush used to collect a Pap smear sample as standard of care. Spatula/cytology brush collection: Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection | 0 | 399 | 0 | 399 | 0 | 399 |
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