Using a device to treat bacterial vaginosis and fungal infections in women
Feasibility/First in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis
This study tests if a new medical device can help premenopausal women get rid of bacterial vaginosis and fungal infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cern Corporation Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Irvine, California and 2 other locations) |
| Trial ID | NCT06933420 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of the Cern Medical Device for treating bacterial vaginosis and fungal vaginitis in premenopausal women. Participants will use the device for 5 consecutive days, with varying usage times depending on their condition, and will engage in regular follow-ups and assessments. The study aims to measure symptom resolution and negative diagnostic tests post-treatment while monitoring any adverse effects. A total of 30 women with confirmed infections will be recruited for this feasibility study.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women with confirmed bacterial vaginosis or fungal vaginitis.
Not a fit: Patients who are postmenopausal or currently using other intravaginal devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a new, effective treatment option for women suffering from bacterial vaginosis and fungal vaginitis.
How similar studies have performed: While this approach is innovative, it is not clear if similar studies have shown success, making this a potentially novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Irvine, California and 2 other locations
- Akerman Med — Irvine, California, United States (Recruiting)
- Akerman Med — Orange, California, United States (Recruiting)
- Akerman Med — Santa Ana, California, United States (Recruiting)
Study contacts
- Study coordinator: Gregg Klang
- Email: gklang@cerndevice.com
- Phone: (949) 306-7160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.