800
Participants
Start Date
August 31, 2014
Primary Completion Date
September 30, 2015
Study Completion Date
December 31, 2015
CNDS Advanced Cervical Scan
"Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with CIN1/2 and women with CIN3+, as described in Section 6.1, Cervical Cytology Enrollment Targets. After the CNDS test, a sample for Hybrid Capture 2 HPV testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated."
Georgia Regents University, Augusta
Lead Sponsor
Guided Therapeutics
INDUSTRY