Using a device to treat bacterial vaginosis and fungal infections in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Cern Medical Device for treating bacterial vaginosis and fungal vaginitis in premenopausal women. Participants will use the device for 5 consecutive days, with varying usage times depending on their condition, and will engage in regular follow-ups and assessments. The study aims to measure symptom resolution and negative diagnostic tests post-treatment while monitoring any adverse effects. A total of 30 women with confirmed infections will be recruited for this feasibility study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis

Exclusion Criteria:

* Postmenopausal status, current use of intravaginal devices, concurrent medical therapy for fungal vaginitis or bacterial vaginosis, recent medical therapy for vaginitis in past 7 days, immunosuppressive medication ≤ 3 months before screening, radiation therapy ≤ 3 months before screening, known allergy to curcumin, acrylic, or silicone, major organ disease or clinically significant infection or conditions that may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy, history of intolerance to intravaginal devices, symptomatic pelvic organ prolapse stage 2 or greater.

Where it's running

• Akerman Med
  Irvine, California, United States Recruiting
• Akerman Med
  Orange, California, United States Recruiting
• Akerman Med
  Santa Ana, California, United States Recruiting

Study contacts

• Study coordinator: Gregg Klang
• Email: gklang@cerndevice.com
• Phone: (949) 306-7160

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using probiotics with antibiotics to prevent bacterial vaginosis recurrence

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  Recruiting Phase 4 Peking University Shenzhen Hospital · Shenzhen, Guangdong · NCT04771728

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.