Pap Smear Collection With the Papette Brush

NCT ID: NCT05034614

Last Updated: 2023-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-18

Study Completion Date

2022-04-01

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.

Conditions

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Cervical Cancer Screening

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pap smears using the Papette

Papette brush used to collect a Pap smear sample as standard of care.

Group Type OTHER

Papette brush collection

Intervention Type DIAGNOSTIC_TEST

Cervical cell brush that gathers collects cervical cells during Pap smear collection

Pap smears using the traditional spatula/cytology brush

Spatula/cytology brush used to collect a Pap smear sample as standard of care.

Group Type OTHER

Spatula/cytology brush collection

Intervention Type DIAGNOSTIC_TEST

Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection

Interventions

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Papette brush collection

Cervical cell brush that gathers collects cervical cells during Pap smear collection

Intervention Type DIAGNOSTIC_TEST

Spatula/cytology brush collection

Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Danielle J. O'Laughlin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danielle O'Laughlin, PA-C, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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21-006131

Identifier Type: -

Identifier Source: org_study_id

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