NCT06933420 Clinical Protocol CERN Feasibility Study
| NCT ID | NCT06933420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cern Corporation |
| Condition | Bacterial Vaginosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2024-11-06 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9 participants in total. It began in 2024-11-06 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06933420 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Bacterial Vaginosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06933420 currently recruiting?
Yes, NCT06933420 is actively recruiting participants. Contact the research team at gklang@cerndevice.com for enrollment information.
Where is the NCT06933420 trial being conducted?
This trial is being conducted at Irvine, United States, Orange, United States, Santa Ana, United States.
Who is sponsoring the NCT06933420 clinical trial?
NCT06933420 is sponsored by Cern Corporation. The trial plans to enroll 9 participants.