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Trial Title:
Study to Evaluate the Effectiveness of the Personal Pap Smear Device™ for Collection of Cervical Cells
NCT ID:
NCT06229275
Condition:
Cervical Cancer Screening
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
pap smear collection
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Pap smear collection using the Personal Pap Smear (PPS) Device
Description:
Diagnostic Test: Use of PPS device to collect cervical cells during pap smear collection.
Arm group label:
Pap smear collection using the Personal Pap Smear (PPS) Device
Intervention type:
Device
Intervention name:
Active Comparator: Pap smear collection using the Rovers Cervex-Brush
Description:
Diagnostic Test: Use of Rovers Cervex-Brush to collect cervical cells during pap smear
collection.
Arm group label:
Pap smear collection using the Rovers Cervex-Brush
Summary:
This purpose of this research study is to determine the effectiveness of the Personal Pap
Smear TM Device to collect adequate cervical cell samples for cytology examination when
compared with the Rover Cervex-Brush (Cervix-Examination Brush).
Detailed description:
To determine the effectiveness of the Personal Pap Smear TM Device to collect adequate
(as defined by Bethesda Guidelines 2014) cervical cell samples for cytology examination
as compared with the Rover Cervex-Brush (Cervix-Examination Brush).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult women, aged 21-65 years old.
- Do not have any medical or psychiatric condition affecting the ability to give
voluntary informed consent.
- Be able to read and understand English
Exclusion Criteria:
- Participants currently on menses
- Inability to provide Informed Consent
- Previous total hysterectomy
- History of radiation treatment for cervical cancer
- Pregnancy
- Medical condition that interferes with conduct of study, in investigator's opinion
- Evidence of active cervical infection requiring treatment
- Known bleeding diathesis
Gender:
Female
Minimum age:
21 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
February 2, 2024
Completion date:
March 30, 2026
Lead sponsor:
Agency:
Morehouse School of Medicine
Agency class:
Other
Collaborator:
Agency:
GyneConcepts, Inc.
Agency class:
Other
Source:
Morehouse School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06229275
