Bacterial VaginosisNCT06933420
Clinical Protocol CERN Feasibility Study
A study testing Cern Device in people with Bacterial Vaginosis and Fungal Vaginal Infections, run by Cern Corporation at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Fungal Vaginal Infections
- What is being tested?
- Cern Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Nov 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Akerman Med
Irvine, California, 92618
Allan Akerman, MD, 714-914-9949, allan_akerman@yahoo.com
- Recruiting
Akerman Med
Orange, California, 92868
Allan Akerman, MD, 714-914-9949, allan_akerman@yahoo.com
- Recruiting
Akerman Med
Santa Ana, California, 92707
Allan Akerman, MD, 714-914-9949, allan_akerman@yahoo.com
About this study
Official title: Feasibility/First in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis
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.
Read the detailed 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.
- Conditions
- Bacterial Vaginosis, Fungal Vaginal Infections
- Being tested
- Cern Device
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cern Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 7 days after treatment completion
Secondary outcomes (1)
Safety of the Cern Device
Number of participants reporting any device-related adverse events (e.g., discomfort, irritation, pain) during or after use of the device. Events will be captured via daily treatment diaries, daily telehealth check-ins, and post-treatment follow-up calls.
Measured: Day 1 to Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start6 Nov 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cern Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933420
- Sponsor's protocol ID
- CERN-PR-001
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility/First in Human Study of Visible Spectrum, Low Level, Microbicidal Light-based Intravaginal Therapy for Treatment of Yeast and Bacterial Vaginitis
- ClinicalTrials.gov ID
- NCT06933420
- Acronym / sponsor ID
- CERN-PR-001
- Conditions
- Bacterial Vaginosis, Fungal Vaginal Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Cern CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bacterial Vaginosis and Fungal Vaginitis | Experimental | Device: Cern DeviceFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirm symptomatic and laboratory-confirmed bacterial vaginosis or fungal vaginitis
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cern DeviceThe 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. | Device | Bacterial Vaginosis and Fungal Vaginitis |
Primary outcome
Resolution of Clinical Symptoms
Time frame: Day 1 to Day 28 (post-treatment)
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.
Negative Diagnostic Test Result
Time frame: Within 7 days after treatment completion
Number of participants with a negative laboratory test for bacterial vaginosis or fungal vaginitis.
1 secondary outcome
Safety of the Cern Device
Time frame: Day 1 to Day 45
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cern Device in people with Bacterial Vaginosis and Fungal Vaginal Infections, run by Cern Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregg Klang ((949) 306-7160, gklang@cerndevice.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Clinical Symptoms (time frame: Day 1 to Day 28 (post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.