Cern Device for Bacterial Vaginosis and Yeast Infection

Recruiting at 2 trial locations

Overseen By Gregg Klang

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cern Corporation

Must not be taking: Immunosuppressants, others

Disqualifiers: Postmenopausal, Pregnancy, Major organ disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

Duration: 1 week

9 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for premenopausal women with bacterial vaginosis or yeast infections. Participants will use the Cern device intravaginally, attend teleconferences and clinic visits, and keep a study diary.

Inclusion Criteria

I have symptoms and lab tests confirming bacterial vaginosis or a fungal infection.

Exclusion Criteria

Current use of intravaginal devices

Known allergy to curcumin, acrylic, or silicone

Pregnancy or plans for pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the intravaginal Cern device daily for 5 consecutive days

1 week

Daily telehealth check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

45 days

Weekly follow-ups and a final assessment at 28 days post-treatment

Treatment Details

Interventions

• Cern Device

Trial Overview The Cern device is being tested to see if it can treat bacterial vaginosis and fungal vaginitis by resolving symptoms and achieving negative diagnostic tests after 5 days of use.

Participant Groups

Group I: Bacterial Vaginosis and Fungal Vaginitis Experimental Treatment 1 Intervention

For bacterial vaginosis, the participants receive 30-minute daily treatment with the Cern Device for 5 days. For fungal vaginitis, the participants receive 60-minute daily treatment with the Cern Device for 5 days.

Who Is Running the Clinical Trial?

Cern Corporation

Lead Sponsor