Clinical Protocol CERN Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCern Corporation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cern Device
DeviceThe Cern Device is an Intravaginal device utilizing low level microbicidal visible light at a 450nm low level microbicidal light, in visible spectrum for treatment of vaginitis, including both bacterial vaginosis and fungal vaginitis.
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: Bacterial Vaginosis and Fungal VaginitisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Resolution of Clinical Symptoms
Number of participants reporting resolution of vaginal discharge, itching, burning, and/or irritation, assessed using a symptom severity scale with the following levels: none, mild, moderate, or severe. Improvement is defined as a reduction in symptom severity to "none" or "mild" for all reported symptoms.
Time frame
Day 1 to Day 28 (post-treatment)2
Negative Diagnostic Test Result
Number of participants with a negative laboratory test for bacterial vaginosis or fungal vaginitis.
Time frame
Within 7 days after treatment completionSecondary outcomes
1
Safety of the Cern Device
Number of participants reporting any device-related adverse events (e.g., discomfort, irritation, pain) during or after use of the device. Events will be captured via daily treatment diaries, daily telehealth check-ins, and post-treatment follow-up calls.
Time frame
Day 1 to Day 45Sponsors and contacts
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Source ClinicalTrials.gov