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

Status unconfirmed

Conditions studied: Cervical Disease

In brief

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.

Key facts

Study ID

NCT02217215

Run by

Guided Therapeutics

People needed

800

Starts

2014-08-01

Expected to finish

2015-12-01

Last updated by the study team

2014-08-15

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgia Regents University — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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