Cern Device for Bacterial Vaginosis and Yeast Infection
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.12345Why 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.12345
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the intravaginal Cern device daily for 5 consecutive days
Follow-up
Participants are monitored for safety and effectiveness after 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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cern Corporation
Lead Sponsor
Citations
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-vaginitisClinical 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 ...
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-studyClinical 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 ...
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