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Clinical Protocol CERN Feasibility Study

Cern Corporation · NCT06933420

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
9
US sites recruiting
3
Study start
November 6, 2024
Record last updated
April 18, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Cern Device

Conditions: Bacterial Vaginosis; Fungal Vaginal Infections

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Akerman Med

    Irvine, CA 92618

    Site contact: Allan Akerman, MD · 714-914-9949 · allan_akerman@yahoo.com

  • Akerman Med

    Orange, CA 92868

    Site contact: Allan Akerman, MD · 714-914-9949 · allan_akerman@yahoo.com

  • Akerman Med

    Santa Ana, CA 92707

    Site contact: Allan Akerman, MD · 714-914-9949 · allan_akerman@yahoo.com

Study contacts (from the official record)

  • Gregg Klang · (949) 306-7160 · gklang@cerndevice.com
  • Melanie Santos · (650) 353-6353 · melaniesant@gmail.com
All women’s health studies in California →
Clinical Protocol CERN Feasibility Study (NCT06933420) | Bored Studies