Study of the Cern Intravaginal Device Using Low-Level Visible Light to Treat Bacterial Vaginosis and Fungal Vaginitis in Premenopausal Women

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.

Clinical Protocol CERN Feasibility Study