VaginitisNCT03585049
Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
An observational study of Vaginitis, run by Meir Medical Center at 1 site in Israel.
Trial summary
The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- Vaginal swabs
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2018to 1 Dec 2022
- 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: All patients above 18y that go through a routine vulvovaginal assessment at the clinic
Who may be able to join
- Vulvovaginal complaints
Who cannot join
- Younger than 18y or cannot sign an informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions
Read the detailed description
During the study, the investigators are planning to make a secondary use of vaginal discharge samples that are primarily taken for routine wet mount microscopic diagnostics in a vulvovaginal clinic at the Women's health center, Ramat-Eshkol, Jerusalem.
In order to create an anonymous archive of digital microscopy images, before each swab is disposed of, the investigator will dilute the collected discharge on the swab with 0.5ml Saline into an Eppendorf tube. The diluted discharge will then be applied onto the GynTools LTD VagX tray that is then scanned by a tabletop scanner. At this point the VagX tray will be washed with water, soap and both the swab and tube will be disposed of.
No of participating patients: 1000 Patients age: 18 years and above. Only from patients capable of signing an informed consent.
- Conditions
- Vaginitis
- Being tested
- Vaginal swabs
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal swabsOther
The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of microscopy image archive
Collecting 1000 images
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Oct 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahinoam Lev-Sagie, Meir Medical Center
- Investigators
- Ahinoam LevSagie, M.D., Principal investigator, Clalit Healthcare Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585049
- Sponsor's protocol ID
- 077-18-COM1
- Status last verified
- Mar 2023
- First submitted
- 30 Jun 2018
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be collected except for consent forms which will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
- ClinicalTrials.gov ID
- NCT03585049
- Acronym / sponsor ID
- 077-18-COM1
- Conditions
- Vaginitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 12 Jul 2018 (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 study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions
Detailed description
During the study, the investigators are planning to make a secondary use of vaginal discharge samples that are primarily taken for routine wet mount microscopic diagnostics in a vulvovaginal clinic at the Women's health center, Ramat-Eshkol, Jerusalem.
In order to create an anonymous archive of digital microscopy images, before each swab is disposed of, the investigator will dilute the collected discharge on the swab with 0.5ml Saline into an Eppendorf tube. The diluted discharge will then be applied onto the GynTools LTD VagX tray that is then scanned by a tabletop scanner. At this point the VagX tray will be washed with water, soap and both the swab and tube will be disposed of.
No of participating patients: 1000 Patients age: 18 years and above. Only from patients capable of signing an informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients above 18y that go through a routine vulvovaginal assessment at the clinic
Key inclusion criteria (1 listed)
- Vulvovaginal complaints
Key exclusion criteria (1 listed)
- Younger than 18y or cannot sign an informed consent form
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 |
|---|---|---|
| Vaginal swabsThe protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic | Other | – |
Primary outcome
Creation of microscopy image archive
Time frame: 1 year
Collecting 1000 images
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 15 Mar 2023.
- Individual participant dataSharing planned: No. No IPD will be collected except for consent forms which will not be shared with other researchers.
Related trials for Vaginitis
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. This study is not recruiting at the moment.
Ahinoam LevSagie, M.D. principal investigator
Clalit Healthcare Services
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 Vaginitis, 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 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: finished, as of the sponsor's last update on 15 Mar 2023. 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?
Creation of microscopy image archive (time frame: 1 year). 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 15 Mar 2023.