Status:
UNKNOWN
Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies
Lead Sponsor:
Guided Therapeutics
Conditions:
Cervical Disease
Eligibility:
FEMALE
21+ years
Brief Summary
The purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix.
Detailed Description
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) ba...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT02217215
Start Date
August 1 2014
End Date
December 1 2015
Last Update
August 15 2014
Active Locations (1)
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1
Georgia Regents University
Augusta, Georgia, United States, 30912