A See and Treat Paradigm for Cervical Pre-cancer
Not Applicable
Terminated
- Conditions
- Cervical Pre-cancer
- Registration Number
- NCT02477124
- Lead Sponsor
- Duke University
- Brief Summary
The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 514
Inclusion Criteria
- Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer.
- Age 25 and greater
- Patients of all ethnic backgrounds will be included.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- Children and subjects under 25.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree Up to approximately 10 minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
AIIMS
🇮🇳New Delhi, India
La Liga Contra el Cancer
🇵🇪Lima, Peru
Kilimanjaro Christian Medical Centre
🇹🇿Moshi, Tanzania
University Teaching Hospital
🇿🇲Lusaka, Zambia
Duke University Medical Center🇺🇸Durham, North Carolina, United States