Status:
RECRUITING
Clinical Protocol CERN Feasibility Study
Lead Sponsor:
Cern Corporation
Conditions:
Bacterial Vaginosis
Fungal Vaginal Infections
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 d...
Detailed Description
The CERN Feasibility Study is an interventional clinical trial designed to evaluate the Cern Medical Device in the treatment of bacterial vaginosis and fungal vaginitis. The study assesses both the ef...
Eligibility Criteria
Inclusion
- Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
Exclusion
- 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.
Key Trial Info
Start Date :
November 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06933420
Start Date
November 6 2024
End Date
May 1 2025
Last Update
April 18 2025
Active Locations (3)
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1
Akerman Med
Irvine, California, United States, 92618
2
Akerman Med
Orange, California, United States, 92868
3
Akerman Med
Santa Ana, California, United States, 92707