Cervical Cancer ScreeningNCT05034614
Pap Smear Collection With the Papette Brush
A study testing Papette brush collection and Spatula/cytology brush collection in people with Cervical Cancer Screening, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is comparing Pap smear collection techniques using the Papette brush to traditional spatula and cytology brush for cervical cancer screening Read more about this study
- Who is it for?
- Ages 21 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Papette brush collection and Spatula/cytology brush collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Women, age < 21 or > 64.
- Has vaginal spotting present during cervical sampling.
- Did not give consent to have medical records accessed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pap Smear Collection With the Papette Brush: A Pragmatic Study
This research study is comparing Pap smear collection techniques using the Papette brush to traditional spatula and cytology brush for cervical cancer screening
Read the 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.
- Conditions
- Cervical Cancer Screening
- Being tested
- Papette brush collection, Spatula/cytology brush collection
- Keywords
- Pap Smear Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papette brush collectionDiagnostic test
Cervical cell brush that gathers collects cervical cells during Pap smear collection
Spatula/cytology brush collectionDiagnostic test
Combination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection
| Study group | Role | What they receive |
|---|---|---|
| Pap smears using the Papette | Other | Papette brush used to collect a Pap smear sample as standard of care. Receives: Diagnostic Test: Papette brush collection |
| Pap smears using the traditional spatula/cytology brush | Other | Spatula/cytology brush used to collect a Pap smear sample as standard of care. Receives: Diagnostic Test: Spatula/cytology brush collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specimen Adequacy
Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report
Measured: Baseline
Secondary outcomes (3)
Cervical Bleeding With Collection
Number of subjects to experience bleeding with collection of samples during the Pap smear exam
Measured: Baseline
Collection Time
The amount of time it takes to collect a sample measured in seconds
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start18 Aug 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle J. O'Laughlin, Mayo Clinic
- Investigators
- Danielle O'Laughlin, PA-C, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034614
- Sponsor's protocol ID
- 21-006131
- Status last verified
- Feb 2023
- First submitted
- 30 Aug 2021
- Last updated
- 1 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pap Smear Collection With the Papette Brush: A Pragmatic Study
- ClinicalTrials.gov ID
- NCT05034614
- Acronym / sponsor ID
- 21-006131
- Conditions
- Cervical Cancer Screening
- Keywords
- Pap Smear Collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pap smears using the Papette | Other | Diagnostic Test: Papette brush collectionPapette brush used to collect a Pap smear sample as standard of care. |
| Pap smears using the traditional spatula/cytology brush | Other | Diagnostic Test: Spatula/cytology brush collectionSpatula/cytology brush used to collect a Pap smear sample as standard of care. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Women, age < 21 or > 64.
- Has vaginal spotting present during cervical sampling.
- Did not give consent to have medical records accessed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Papette brush collectionCervical cell brush that gathers collects cervical cells during Pap smear collection | Diagnostic test | Pap smears using the Papette |
| Spatula/cytology brush collectionCombination of extended-tip spatula with endocervical brush that collects cervical cells during Pap smear collection | Diagnostic test | Pap smears using the traditional spatula/cytology brush |
Primary outcome
Specimen Adequacy
Time frame: Baseline
Number of subjects who's samples have cervical cellular adequacy for a satisfactory evaluation indicated on the cytology report
3 secondary outcomes
Cervical Bleeding With Collection
Time frame: Baseline
Collection Time
Time frame: Baseline
Perceived Pain
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle O'Laughlin, PA-C, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papette brush collection and Spatula/cytology brush collection in people with Cervical Cancer Screening, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specimen Adequacy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.