SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
screeening
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Intervention
Name: Mobile OCT M3 scope
Type: Device
Overall Status
Not yet recruiting
Summary
This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test -

Exclusion Criteria: no consent

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Location
Scripps Clinic
San Diego, California, United States
Status:
Start Date
November 2014
Completion Date
September 2015
Sponsors
Scripps Health
Source
Scripps Health
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page