Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies

UnknownOBSERVATIONAL
Enrollment

800

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

September 30, 2015

Study Completion Date

December 31, 2015

Conditions
Cervical Disease
Interventions
DEVICE

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."

Trial Locations (1)

30912

Georgia Regents University, Augusta

Sponsors
All Listed Sponsors
lead

Guided Therapeutics

INDUSTRY