Clinical Protocol CERN Feasibility Study
Recruiting now · Not applicable
Conditions studied: Bacterial Vaginosis, Fungal Vaginal Infections
In brief
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.
Key facts
- Study ID
- NCT06933420
- Run by
- Cern Corporation
- People needed
- 9
- Starts
- 2024-11-06
- Expected to finish
- 2025-05-01
- Last updated by the study team
- 2025-04-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
You may not qualify if…
- 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 is running
- Akerman Med — Irvine, California, United States (enrolling)
- Akerman Med — Orange, California, United States (enrolling)
- Akerman Med — Santa Ana, California, United States (enrolling)
Full record on ClinicalTrials.gov
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