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

Launched by GUIDED THERAPEUTICS · Aug 13, 2014

Keywords

ClinConnect Summary

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 Cervical Intra-epithelial Neoplasia (CIN1/2) and women with CIN3+, as described in Section 6.1, "Cervical Cytology Enrollment Targets". After the Cervical Neoplasia Detection System (CNDS) test, a sample for Hybrid Capture 2 Human papillomavirus (HP...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age 21 or above
• • Able to read or understand and give informed consent
• • Negative pregnancy test or documentation of acceptable birth control
• • Willing to undergo colposcopy, cytology (if required) and HPV testing on day of study
• • Abnormal cytology result within 120 days of CNDS test for Phase 2 subjects
• Exclusion Criteria:
• • Pregnancy
• • Menstruating
• • Previous cervical neoplasia
• • Prior hysterectomy
• * Conditions relating to the cervix that would render the test difficult to perform, including but not limited to:
• • Excessive blood or mucus that cannot be removed Abnormal congenital cervix Unable to tolerate speculum or CNDS single use cervical guide