Cervical Cancer Screening Clinical Trial
Official title:
A Phase III Cross-Over Comparative Study to Evaluate the Effectiveness of the Rover Cervex-Brush Device vs. the Personal Pap Smear Device™ for Collection of Cervical Cells for Detecting Cervical Dysplasia or Neoplasia
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).
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | March 30, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Morehouse School of Medicine | GyneConcepts, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the samples for the Predicate Device versus PPS device | Data of Adequate versus Inadequate will be reported to include a positive percent agreement (PPA) defined as PPA= A/(A+C) and the negative percent agreement (NPA) defined as NPA = D/(B+D) along with their 95% confidence bounds using the Clopper-Pearson method. | Baseline | |
Secondary | The Comparison of Cell Types of the PPS Device versus the Predicate Device | The PPS Device and the Predicate Device cell types will be measured against the 2014 Besthesda cytology categories that will be displayed in a 8 x 8 contingency table. | Baseline |
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