Recruiting

Observational Study

Sponsor:

Cern Corporation

Code:

NCT06933420

Conditions

Bacterial Vaginosis

Fungal Vaginal Infections

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cern Device

Study Details

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.

Conditions

Bacterial Vaginosis

Fungal Vaginal Infections

Study ID

NCT06933420

Start date

Nov 6, 2024

Status verified date

Apr, 2025

Completion date

May, 2025

Anticipated

Primary completion date

May, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

9 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bacterial Vaginosis and Fungal Vaginitis

For bacterial vaginosis, the participants receive 30-minute daily treatment with the Cern Device for 5 days. For fungal vaginitis, the participants receive 60-minute daily treatment with the Cern Device for 5 days.

Interventions

Cern Device

The Cern Device is an Intravaginal device utilizing low level microbicidal visible light at a 450nm low level microbicidal light, in visible spectrum for treatment of vaginitis, including both bacterial vaginosis and fungal vaginitis.

Primary outcome measure

  • Resolution of Clinical Symptoms [ Time Frame: Day 1 to Day 28 (post-treatment) ]
  • Negative Diagnostic Test Result [ Time Frame: Within 7 days after treatment completion ]

Central Contacts and Locations

Central contacts

Gregg Klang

(949) 306-7160gklang@cerndevice.com

Melanie Santos

(650) 353-6353melaniesant@gmail.com

Locations

Akerman Med

Recruiting

Irvine, California, United States, 92618

Contacts

Allan Akerman, MD

714-914-9949allan_akerman@yahoo.com

Akerman Med

Recruiting

Orange, California, United States, 92868

Contacts

Allan Akerman, MD

714-914-9949allan_akerman@yahoo.com

Akerman Med

Recruiting

Santa Ana, California, United States, 92707

Contacts

Allan Akerman, MD

714-914-9949allan_akerman@yahoo.com

More Information

Sponsor

Cern Corporation

Last update posted

Apr 18, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cern Corporation on 2025-04-18.