Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
Archive of Vaginal Swabs Microscopic Images for the Development of a Rapid Vaginitis Diagnostic Device
1 other identifier
observational
500
1 country
1
Brief Summary
The study goal is to create an archive of microscopy images of various vulvovaginal inflammation conditions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 15, 2023
March 1, 2023
4.2 years
June 30, 2018
March 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Creation of microscopy image archive
Collecting 1000 images
1 year
Interventions
The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic
Eligibility Criteria
All patients above 18y that go through a routine vulvovaginal assessment at the clinic
You may qualify if:
- Vulvovaginal complaints
You may not qualify if:
- Younger than 18y or cannot sign an informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clalit Women's Health Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahinoam LevSagie, M.D.
Clalit Healthcare Services
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 30, 2018
First Posted
July 12, 2018
Study Start
October 1, 2018
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share
No IPD will be collected except for consent forms which will not be shared with other researchers.