Clinical Protocol CERN Feasibility Study

Last updated: April 10, 2025
Sponsor: Cern Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sexually Transmitted Diseases (Stds)

Vaginal Infection

Gynecological Infections

Treatment

Cern Device

Clinical Study ID

NCT06933420
CERN-PR-001
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Postmenopausal status, current use of intravaginal devices, concurrent medicaltherapy for fungal vaginitis or bacterial vaginosis, recent medical therapy forvaginitis 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 conditionsthat may affect clinical assessment of vaginitis, pregnancy or plans for pregnancy,history of intolerance to intravaginal devices, symptomatic pelvic organ prolapsestage 2 or greater.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: Cern Device
Phase:
Study Start date:
November 06, 2024
Estimated Completion Date:
May 31, 2025

Study 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 efficacy and safety of this innovative technology, which combines 450nm visible spectrum light with a natural photosensitizer (carboxy methyl cellulose and curcumin). The primary objective is to determine the device's effectiveness by measuring symptom resolution and negative diagnostic tests post-treatment. The secondary objective focuses on safety, monitoring adverse effects and patient tolerance during and after treatment. The study design involves recruiting up to 30 premenopausal women with culture-confirmed bacterial vaginosis or fungal vaginitis. Participants are divided into two groups, in the bacterial vaginosis group, the device is used for 30 minutes daily for 5 consecutive days. And in the fungal vaginitis group, the device is used for 60 minutes daily for 5 consecutive days. Following treatment, participants undergo a 45-day follow-up period, which includes daily telecom check-ins during treatment, weekly follow-ups, and a final assessment at 28 days post-treatment. Adherence is tracked through daily diaries and telecom follow-ups, ensuring treatment compliance, effectiveness monitoring, and adverse reaction tracking. Treatment success is determined by self-reported symptom resolution and negative diagnostic cultures, while safety is assessed through self-reported adverse events and clinical examinations.

Connect with a study center

  • Akerman Med

    Irvine, California 92618
    United States

    Active - Recruiting

  • Akerman Med

    Orange, California 92868
    United States

    Active - Recruiting

  • Akerman Med

    Santa Ana, California 92707
    United States

    Active - Recruiting

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