Actively Recruiting
Clinical Protocol CERN Feasibility Study
Led by Cern Corporation · Updated on 2025-04-18
9
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Protocol CERN Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
You will not qualify if you...
- 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 within 3 months before screening
- Radiation therapy within 3 months before screening
- Known allergy to curcumin, acrylic, or silicone
- Major organ disease or clinically significant infection or conditions affecting vaginitis assessment
- Pregnancy or plans for pregnancy
- History of intolerance to intravaginal devices
- Symptomatic pelvic organ prolapse stage 2 or greater
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Akerman Med
Irvine, California, United States, 92618
Actively Recruiting
2
Akerman Med
Orange, California, United States, 92868
Actively Recruiting
3
Akerman Med
Santa Ana, California, United States, 92707
Actively Recruiting
Research Team
G
Gregg Klang
CONTACT
M
Melanie Santos
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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