VaginitisNCT04816903
Gyni™ Study With Leumit Health Services
A study testing Gyni in people with Vaginitis, run by GynTools Ltd. at 4 sites in Israel.
Trial summary
About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- Gyni
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesIsrael
- Study dates
- 7 Mar 2021to 7 Mar 2022
- Phase
- Interventional
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥18 years old
- Able to read, understand and sign an informed consent form
- At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain.
Who cannot join
- Patients under the age of 18 years
- Patient is unfit to provide an informed consent
- Patient with vaginal bleeding, including menstruation within past 24 hours21
- Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22
- Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)
Trial locations and contacts
4 sites in 1 country.
Israel4 sites, 4 recruiting
- Recruiting
Leumit women's health
Jerusalem, 9439000
Avishai Malkiel, MD, 972587424564
- Recruiting
Kfar Yasif clinic
Kfar Yasif, North, 2490800
Marwan Odeh, MD, 972507887486
- Not yet recruiting
Kiryat Bialik, Leumit health services (HMO) Women's health clinic
Kiryat Bialik, North, 2709325
Lior Lowenstein, Professor, 972502061434
- Not yet recruiting
Netanya Women's health center, Leumit Health services (HMO)
Netanya, Central District, 4240200
Amir L Weintraub, MD, +972508685330
About this study
Official title: Gyni™ System Pilot Study With Leumit Health Services - Prospective Study
About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today.
Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes.
The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.
- Conditions
- Vaginitis
- Being tested
- Gyni
- Keywords
- gynecology, IVD
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GyniDiagnostic test
Vaginal discharge collection
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic vaginitis patients | Experimental | All participants will be enrolled according to their complaints, All will be tested by the Gyni system, Only in the second group the physician will be unblinded to the Gyni results. Receives: Diagnostic Test: Gyni |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison parameter
Number of visits (from initial visit until the cause of vaginitis is detected)
Measured: 12 months
Comparison parameter
Total cost of medication
Measured: 12 months
Comparison parameter
Total Cost of lab tests
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 posted25 Mar 2021
- Study start7 Mar 2021
- Primary completion7 Mar 2022 (estimated)
- Study completion7 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Group-A Blinded Group-B Unblinded
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GynTools Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leumit Health Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816903
- Sponsor's protocol ID
- CL00000-16
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gyni™ System Pilot Study With Leumit Health Services - Prospective Study
- ClinicalTrials.gov ID
- NCT04816903
- Acronym / sponsor ID
- CL00000-16
- Conditions
- Vaginitis
- Keywords
- gynecology, IVD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- GynTools Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Leumit Health Services
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 7 Mar 2022 (estimated)
- Study completion
- 7 Mar 2022 (estimated)
- First posted
- 25 Mar 2021 (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.
About one third of the women referring to gynecological clinics present with vulvovaginal inflammation symptoms (vaginitis) possibly caused by seven different conditions or mixed infections. The Gyni™ system is intended to provide physicians with the means to obtain an accurate, fast and inexpensive diagnosis which is unavailable today.
Gyni™ is comprised of a compact tabletop scanner, a disposable sample collector and a cloud based algorithm that provides a suggested diagnosis within 5 minutes.
The trial is a prospective evaluation of the cost-effectiveness of using Gyni™ by comparing its usage outcomes in a practice setting to the outcomes obtained using the current standard of care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Group-A Blinded Group-B Unblinded
| Arm | Type | Receives |
|---|---|---|
| Symptomatic vaginitis patients | Experimental | Diagnostic Test: GyniAll participants will be enrolled according to their complaints, All will be tested by the Gyni system, Only in the second group the physician will be unblinded to the Gyni results. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female ≥18 years old
- Able to read, understand and sign an informed consent form
- At least one of the following: abnormal vaginal discharge, odor, vulvovaginal itch, burning, irritation, dyspareunia, vaginal dryness or pain.
Key exclusion criteria (5 listed)
- Patients under the age of 18 years
- Patient is unfit to provide an informed consent
- Patient with vaginal bleeding, including menstruation within past 24 hours21
- Patient who used intra vaginal preparations within 72 hours prior to study enrollment (antimicrobials, spermicides, lubricants, diaphragm)22
- Uninterpretable sample (e.g. patients who used vaginal creams or lubricants before the visit or insufficient sampling material)
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 |
|---|---|---|
| GyniVaginal discharge collection | Diagnostic test | Symptomatic vaginitis patients |
Primary outcome
Comparison parameter
Time frame: 12 months
Number of visits (from initial visit until the cause of vaginitis is detected)
Comparison parameter
Time frame: 12 months
Total cost of medication
Comparison parameter
Time frame: 12 months
Total Cost of lab tests
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Vaginitis
Enrolling by invitationObservational study
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
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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)
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Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gyni in people with Vaginitis, run by GynTools Ltd. at 4 sites 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yardenna Glader (+972525522116, yardenna@gyntools.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison parameter (time frame: 12 months). The study lists 3 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 25 Mar 2021.