Actively Recruiting
Feasibility Study of Visible Light Intravaginal Therapy for Bacterial Vaginosis and Fungal Vaginitis
Led by Cern Corporation · Updated on 2025-04-18
9
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Cern Device, an intravaginal tool using low level visible light combined with a natural photosensitizer, to treat bacterial vaginosis and fungal vaginitis in premenopausal women. This trial aims to determine if the device can resolve symptoms and produce negative diagnostic tests after treatment, while also monitoring safety and any medical problems participants may experience. Participants are assigned to one of two groups based on their condition. Those with bacterial vaginosis receive 30 minutes of daily treatment with the Cern Device for 5 consecutive days, while those with fungal vaginitis receive 60 minutes of daily treatment for 5 days. After treatment, participants enter a 45-day follow-up period including daily teleconference check-ins during treatment, weekly follow-ups, and a final assessment 28 days post-treatment. During the study, participants keep a daily diary and attend clinic visits for evaluations. Researchers assess symptom resolution, diagnostic test results, and safety by monitoring adverse events and clinical exams. Treatment adherence and tolerance are tracked through telecom follow-ups and self-reporting. The entire participation lasts through treatment and the 45-day observation period to gather comprehensive data on effectiveness and safety.
CONDITIONS
Brief Title
Clinical Protocol CERN Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
- Female premenopausal adults aged 18 years and older
You will not qualify if you...
- Postmenopausal status
- Current use of intravaginal devices
- Concurrent medical therapy for fungal vaginitis or bacterial vaginosis
- Recent medical therapy for vaginitis within the past 7 days
- Use of immunosuppressive medication within 3 months before screening
- Radiation therapy within 3 months before screening
- Known allergy to curcumin, acrylic, or silicone
- Major organ disease or clinically significant infection affecting vaginitis assessment
- Pregnancy or plans for pregnancy
- History of intolerance to intravaginal devices
- Symptomatic pelvic organ prolapse stage 2 or greater
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 5 consecutive days
Participants receive daily intravaginal therapy with the Cern Device for bacterial vaginosis or fungal vaginitis. Treatment duration depends on the condition: 30 minutes daily for 5 days for bacterial vaginosis or 60 minutes daily for 5 days for fungal vaginitis.
Daily telecom check-ins during treatment
Duration - 45 days post-treatment
Participants are monitored for safety and effectiveness of the treatment, including adverse event tracking and symptom resolution assessments.
Weekly follow-up visits and a final assessment at 28 days post-treatment
Trial Site Locations
Total: 3 locations
1
Akerman Med
Irvine, California, United States, 92618
Actively Recruiting
2
Akerman Med
Orange, California, United States, 92868
Actively Recruiting
3
Akerman Med
Santa Ana, California, United States, 92707
Actively Recruiting
Research Team
G
Gregg Klang
M
Melanie Santos
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here