Clinical Protocol CERN Feasibility Study

Part of paid clinical trials in Irvine, California.

Sponsor
Cern Corporation
Study ID
NCT06933420
Status
Recruiting
Apply to this trial

Conditions

  • Bacterial Vaginosis
  • Fungal Vaginal Infections

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cern Device — 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.

Study Details

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.

Key Dates

Start date
Nov 6, 2024
Status verified
Apr 2025
Primary completion
May 31, 2025
Completion
May 31, 2025

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Resolution of Clinical Symptoms [ Time Frame: Day 1 to Day 28 (post-treatment) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Akerman MedIrvineCalifornia92618
Allan Akerman, MD
[email protected]
714-914-9949
Akerman MedOrangeCalifornia92868
Allan Akerman, MD
[email protected]
714-914-9949
Akerman MedSanta AnaCalifornia92707
Allan Akerman, MD
[email protected]
714-914-9949

Find similar trials in Irvine, CA

By research site
Akerman Med· Irvine, CAAkerman Med· Orange, CAAkerman Med· Santa Ana, CA

Related Studies