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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Cern Device to determine its effectiveness in treating bacterial vaginosis and yeast infections in premenopausal women. Researchers aim to assess whether the device can clear symptoms and pass follow-up tests, while also monitoring for any side effects. Participants will use the device for 5 days, engage in teleconferences and weekly check-ins, visit the clinic, and maintain a study diary. Women who currently have bacterial vaginosis or a yeast infection and have received a medical diagnosis are suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial requires that you do not use any current medical therapy for fungal vaginitis or bacterial vaginosis. If you have used such treatments in the past 7 days, you may not be eligible to participate.

What prior data suggests that the Cern Device is safe for treating bacterial vaginosis and fungal vaginitis?

Research shows that the Cern device is a new treatment being tested for safety and effectiveness in treating bacterial vaginosis and yeast infections. As this is the first human trial, specific safety data is not yet available. However, the device has shown promise in earlier tests, leading to this feasibility study.

Feasibility studies are early tests to determine if a treatment is safe enough for small groups of people. Unknown side effects may occur, so participants will be closely monitored to address any issues promptly.

The Cern device aims to treat infections without drugs, potentially reducing drug-related side effects. Participants will use the device for only five days, which may also help limit potential side effects. Overall, the study seeks to gather important information about the device's safety for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for bacterial vaginosis and yeast infections, which often involve antibiotics or antifungal medications, the Cern Device offers a non-drug alternative. This device uses a novel delivery method, providing targeted therapy through daily sessions, which may reduce the risk of side effects commonly associated with oral or topical medications. Researchers are excited because this approach could offer a quicker response, with potential results in just 5 days, and may prevent the resistance issues seen with traditional antibiotic and antifungal treatments.

What evidence suggests that the Cern Device is effective for bacterial vaginosis and fungal vaginitis?

Research has shown that the Cern Device uses special light to kill germs and treat bacterial vaginosis and fungal vaginitis. This treatment differs from others because it doesn't use drugs. Although limited human data exists on its effectiveness, the device targets and removes harmful bacteria and fungi directly. Early results suggest this method could help clear up symptoms and lead to negative test results after treatment. The Cern Device offers a new option for those seeking non-drug treatments for these conditions. Participants in this trial will receive treatment with the Cern Device for either bacterial vaginosis or fungal vaginitis, depending on their condition. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06933420

NCT06933420 | Clinical Protocol CERN Feasibility Study 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/744dc1b12755aa88/nct06933420-light-therapy-yeast-bacterial-vaginitis

Clinical Protocol CERN Feasibility Study | MedPath The goal of this clinical trial is to learn if the intravaginal Cern device works to treat bacterial vaginosis and fungal vaginitis in ...

3. cerndevice.com cerndevice.com/

Cern Corporation Microbicidal Light Treatment for Fungal and Bacterial Vaginosis…Without Drugs. The Cern Device™: A potential breakthrough in treatment.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06933420/clinical-protocol-cern-feasibility-study

Clinical Protocol CERN Feasibility Study 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.

5. clinicaltrialvanguard.com clinicaltrialvanguard.com/executiveinterviews/shining-light-on-womens-health-a-new-non-drug-vaginal-therapy/

Shining Light on Women's Health: A New Non-Drug ... ... device and proprietary gel designed to treat both bacterial vaginosis and fungal vaginitis, which in and of itself is a unique value ...