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NCT05679141
Clinical Correlation Between Self-collected and Physician-collected HPV Screening Kits
Conditions: HPV Infection, Cervical Cancer
Sex: Female
Ages: 21 Years – N/A
Healthy volunteers: 1
Enrollment: 100
Sponsor: Switch Health Solutions Inc.
Summary
The objective of this study is to validate the of the Evalyn®Brush via self-collection to the standard clinician-collected technique using the BD SurePath™ collection vial and Rovers CombiBrush for detection of Human Papillomavirus (HPV).
This study will validate the sensitivity and specificity of the Evalyn Brush with the future goal of making this testing approach available for self-collection in the future.
Eligibility Criteria
Inclusion Criteria:Participant visiting the study site for a potential OB/GYN purposeParticipant >= 21 years of ageParticipant has a cervixExclusion Criteria:Currently menstruatingCurrently pregnant or within 3 months following pregnancyUtilized vaginal products within past 48 hrs.Experiencing any of following symptoms:Pain in lower abdomen Fever Unusual or heavy vaginal discharge Pain / bleeding when having intercourse Painful or frequent urination
Source: ClinicalTrials.gov (NCT05679141). StuddyBuddy aggregates publicly available trial information.
