An observational study in Vaginitis, sponsored by Meir Medical Center. Completed at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by Meir Medical Center · Observational
The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions
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.
98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.
This study's enrollment of 500 is above the median of 140 across 22 observational studies indexed under Vaginitis.
Browse Vaginitis studies →Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients above 18y that go through a routine vulvovaginal assessment at the clinic
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Vulvovaginal complaints
Exclusion Criteria:
Younger than 18y or cannot sign an form
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic
Creation of microscopy image archive
Collecting 1000 images
Time frame: 1 year
Plan to share: No — No IPD will be collected except for consent forms which will not be shared with other researchers.
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Dec 2022, 50 months.
Of 12 observational studies under Vaginitis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 50. This study's 50 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.