RecruitingNot ApplicableNCT06933420

Clinical Protocol CERN Feasibility Study

Feasibility/First in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis

Sponsor

Cern Corporation

Enrollment

9 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Bacterial vaginosis Fungal Vaginal Infections

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cern Device for people with bacterial vaginosis and fungal vaginal infections. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECern 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.