NCT06933420

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 21, 2025

Last Update Submit

April 10, 2025

Conditions

Bacterial VaginosisFungal Vaginal Infections

Outcome Measures

Primary Outcomes (2)

  • Resolution of Clinical Symptoms

    Number of participants reporting resolution of vaginal discharge, itching, burning, and/or irritation, assessed using a symptom severity scale with the following levels: none, mild, moderate, or severe. Improvement is defined as a reduction in symptom severity to "none" or "mild" for all reported symptoms.

    Day 1 to Day 28 (post-treatment)

  • Negative Diagnostic Test Result

    Number of participants with a negative laboratory test for bacterial vaginosis or fungal vaginitis.

    Within 7 days after treatment completion

Secondary Outcomes (1)

  • Safety of the Cern Device

    Day 1 to Day 45

Study Arms (1)

Bacterial Vaginosis and Fungal Vaginitis

EXPERIMENTAL

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.

Device: Cern Device

Interventions

Cern DeviceDEVICE

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.

Bacterial Vaginosis and Fungal Vaginitis

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPremenopausal women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Akerman Med

Irvine, California, 92618, United States

RECRUITING

Akerman Med

Orange, California, 92868, United States

RECRUITING

Akerman Med

Santa Ana, California, 92707, United States

RECRUITING

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Gregg Klang

CONTACT

(949) 306-7160gklang@cerndevice.com

Melanie Santos

CONTACT

(650) 353-6353melaniesant@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2025

First Posted

April 18, 2025

Study Start

November 6, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Locations

US(3)