Status:
UNKNOWN
Evaluation of the Biop Colposcopy System's Safety and Performance (Accuracy of Its Registration Procedure)
Lead Sponsor:
BIOP Medical
Conditions:
Cervical Cancer Screening
Eligibility:
FEMALE
22-65 years
Phase:
NA
Brief Summary
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure betwe...
Detailed Description
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure betwe...
Eligibility Criteria
Inclusion
- Females, ages 22 to 65 years old
- Referred for colposcopy, following abnormal cervical cytology
- Subject provides signed informed consent
Exclusion
- Currently pregnant or nursing
- Currently menstruating
- Currently has intrauterine device (IUD)
- Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis, polycytemia vera.
- Diagnosed with pathologies that affect blood coagulation, the immune system or undergoing any treatment that interfere with coagulation or the immune system
- HIV-positive status
- Psychological instability, inappropriate attitude or motivation
- Use of any additional experimental drug or device or participation in another clinical study within the past 30 days
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03750214
Start Date
May 1 2020
End Date
December 1 2020
Last Update
January 18 2020
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