Bacterial VaginosisNCT04219605
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
An observational study of Bacterial Vaginosis and Candida Albicans Vulvovaginitis, run by Meir Medical Center at 1 site in Israel.
Trial summary
Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Candida Albicans Vulvovaginitis, Candida Vulvovaginitis
- How many people
- 226 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2020to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with vulvovaginal symptoms
Who may be able to join
- Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain
- Age >= 18y
Who cannot join
- Age < 18y
- Not eligible to sign an informed consent
- Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence.
- During menstruation
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.
Read the detailed description
During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).
One additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.
The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator
- Conditions
- Bacterial Vaginosis, Candida Albicans Vulvovaginitis, Candida Vulvovaginitis, Trichomonas Vaginitis, Atrophic Vaginitis, Desquamative Inflammatory Vaginitis
- Medical subject headings
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal, Trichomonas Vaginitis, Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic vaginitis patients | Symptomatic patients evaluated in the clinic for vulvovaginal symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
Specificity and sensitivity of the device performance in regard to vaginitis conditions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Dec 2020
- Primary completion30 Oct 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Avraham Ben Chetrit, MD, Principal investigator, Clalit HMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219605
- Sponsor's protocol ID
- 0120-19-COM1
- Status last verified
- Nov 2024
- First submitted
- 5 Jan 2020
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lev-Sagie A, Strauss D, Ben Chetrit A. Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis. NPJ Digit Med. 2023 Apr 13;6(1):66. doi: 10.1038/s41746-023-00815-w.
PubMed 37055473
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
- ClinicalTrials.gov ID
- NCT04219605
- Acronym / sponsor ID
- 0120-19-COM1
- Conditions
- Bacterial Vaginosis, Candida Albicans Vulvovaginitis, Candida Vulvovaginitis, Trichomonas Vaginitis, Atrophic Vaginitis, Desquamative Inflammatory Vaginitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 7 Jan 2020 (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.
Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.
Detailed description
During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).
One additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.
The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic vaginitis patients | – | –Symptomatic patients evaluated in the clinic for vulvovaginal symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with vulvovaginal symptoms
Key inclusion criteria (2 listed)
- Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain
- Age >= 18y
Key exclusion criteria (4 listed)
- Age < 18y
- Not eligible to sign an informed consent
- Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence.
- During menstruation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance
Time frame: 12 months
Specificity and sensitivity of the device performance in regard to vaginitis conditions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 37055473Lev-Sagie A, Strauss D, Ben Chetrit A. Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis. NPJ Digit Med. 2023 Apr 13;6(1):66. doi: 10.1038/s41746-023-00815-w.
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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. This study is not recruiting at the moment.
Avraham Ben Chetrit, MD principal investigator
Clalit HMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Vaginosis and Candida Albicans Vulvovaginitis, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219605, which also lists 1 linked publication.
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 13 May 2025; AzTrials last refreshed its copy on 26 Oct 2026.