Clinical trial NCT06933420: Clinical Protocol CERN Feasibility Study
Official title: Feasibility/First in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis
Fungal Vaginal Infections
Lead sponsor: Cern Corporation
Sponsor class: INDUSTRY
First posted: 2025-04-18
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The CERN Feasibility Study is an interventional clinical trial designed to evaluate the Cern Medical Device in the treatment of bacterial vaginosis and fungal vaginitis. The study assesses both the efficacy and safety of this innovative technology, which combines 450nm visible spectrum light with a natural photosensitizer (carboxy methyl cellulose and curcumin). The primary objective is to determine the device's effectiveness by measuring symptom resolution and negative diagnostic tests post-treatment. The secondary objective focuses on safety, monitoring adverse effects and patient tolerance during and after treatment. The study design involves recruiting up to 30 premenopausal women with culture-confirmed bacterial vaginosis or fungal vaginitis. Participants are divided into two groups, in the bacterial vaginosis group, the device is used for 30 minutes daily for 5 consecutive days. And in the fungal vaginitis group, the device is used for 60 minutes daily for 5 consecutive days. Following treatment, participants undergo a 45-day follow-up period, which includes daily telecom check-ins during treatment, weekly follow-ups, and a final assessment at 28 days post-treatment. Adherence is tracked through daily diaries and telecom follow-ups, ensuring treatment compliance, effectiveness monitoring, and adverse reaction tracking. Treatment success is determined by self-reported symptom resolution and negative diagnostic cultures, while safety is assessed through self-reported adverse events and clinical examinations.

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.

Primary outcomes:
measure: Resolution of Clinical Symptoms
timeFrame: Day 1 to Day 28 (post-treatment)
measure: Negative Diagnostic Test Result
timeFrame: Within 7 days after treatment completion
Secondary outcomes:
measure: Safety of the Cern Device
timeFrame: Day 1 to Day 45
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Akerman Med
state: California
city: Orange
country: United States
facility: Akerman Med
state: California
city: Santa Ana
country: United States
facility: Akerman Med
state: California
Study officials:
References: