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Clinical Protocol CERN Feasibility Study
Sponsor: Cern Corporation
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.
Official title: Feasibility/First in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2024-11-06
Completion Date
2025-05
Last Updated
2025-04-18
Healthy Volunteers
No
Interventions
Cern Device
The 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.
Locations (3)
Akerman Med
Irvine, California, United States
Akerman Med
Orange, California, United States
Akerman Med
Santa Ana, California, United States