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Clinical Protocol CERN Feasibility Study
Feasibility/First in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis Exclusion Criteria: * Postmenopausal status, current use of intravaginal devices, concurrent medical therapy for fungal vaginitis or bacterial vaginosis, recent medical therapy for vaginitis in past 7 days, immunosuppressive medication ≤ 3 months before screening, radiation therapy ≤ 3 months before screening, known allergy to curcumin, acrylic, or silicone, major organ disease or clinically significant infection or conditions that may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy, history of intolerance to intravaginal devices, symptomatic pelvic organ prolapse stage 2 or greater.
About the study
The goal of this clinical trial is to learn if the intravaginal Cern device works to treat bacterial vaginosis and fungal vaginitis in premenopausal women. It will also learn about the safety of the device. The main questions it aims to answer are: Does the device accomplish symptom resolution and negative diagnostic tests post-treatment? What medical problems do participants have when using the intravaginal device? Participants will use the investigational intravaginal device for 5 consecutive days, participate in teleconferences and weekly follow-ups, attend in-clinic visits, and maintain a study diary.
What is being tested
- Cern Device (device)
Sponsor: Cern Corporation · Participants: 9 · Started: Nov 6, 2024
Contact the study team
- Gregg Klang · Phone: (949) 306-7160
- Melanie Santos · Phone: (650) 353-6353
Official record on ClinicalTrials.gov — NCT06933420
Locations in the U.S.
| California | Akerman Med, Irvine Akerman Med, Orange Akerman Med, Santa Ana |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.