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Completed

NCT Number: NCT05034614

Pap Smear Collection With the Papette Brush

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

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Key information

Conditions

Cervical Cancer Screening

Age range

21 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Papette brush collection

Diagnostic Test

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

Spatula/cytology brush collection

Diagnostic Test

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

Primary outcomes

  1. Specimen Adequacy

    Time frame: Baseline

    Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report

Secondary outcomes

  1. Cervical Bleeding With Collection

    Time frame: Baseline

    Number of subjects to experience bleeding with collection of samples during the Pap smear exam

  2. Collection Time

    Time frame: Baseline

    The amount of time it takes to collect a sample measured in seconds

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pap Smear Collection With the Papette Brush: A Pragmatic Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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