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CERN Feasibility Study for Bacterial Vaginosis and Fungal Vaginal Infections

This study is testing an intravaginal device called the Cern Device to see if it can safely and effectively treat bacterial vaginosis and fungal vaginal infections in premenopausal women. The Cern Device uses a special type of visible light (450nm) along with a natural photosensitizer (carboxy methyl cellulose and curcumin) to treat these conditions. To join, you must be a woman aged 18 or older with confirmed bacterial vaginosis or fungal vaginitis. The study will consider the treatment successful if your symptoms go away and diagnostic tests are negative after using the device. This study is currently unclear on its recruitment status, but plans to enroll 9 participants.

Study design
This is an interventional study designed to evaluate the Cern Medical Device. It plans to enroll 9 premenopausal women.
What's involved
You would 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.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 45-day follow-up period after treatment, with a final assessment at 28 days post-treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06933420

Clinical Protocol CERN Feasibility Study

Recruiting
NAAges 18+InterventionalTreatment
Cern Corporation
~9 participants
Updated 2025-04-18 on ClinicalTrials.gov
What's tested:Cern Device

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resolution of Clinical Symptoms
Measured over Day 1 to Day 28 (post-treatment)
+1 more outcome measured

Conditions

Bacterial Vaginosis
Fungal Vaginal Infections

Explore related trials

Bacterial VaginosisFungal Vaginal Infections

NCT06933420

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Akerman Med

    Irvine, Californiastudy coordinator listed

    Recruiting

  • Akerman Med

    Orange, Californiastudy coordinator listed

    Recruiting

  • Akerman Med

    Santa Ana, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Gregg Klang
[email protected]
(949) 306-7160
Email the study team

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Eligibility criteria

Inclusion

Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis

Exclusion

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.

What this trial measures

  • Resolution of Clinical SymptomsDay 1 to Day 28 (post-treatment)

    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.

  • Negative Diagnostic Test ResultWithin 7 days after treatment completion

    Number of participants with a negative laboratory test for bacterial vaginosis or fungal vaginitis.