NCT04219605

Brief Summary

Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

May 13, 2025

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

January 5, 2020

Last Update Submit

May 8, 2025

Conditions

Bacterial VaginosisCandida Albicans VulvovaginitisCandida VulvovaginitisTrichomonas VaginitisAtrophic VaginitisDesquamative Inflammatory Vaginitis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance

    Specificity and sensitivity of the device performance in regard to vaginitis conditions

    12 months

Study Arms (1)

Symptomatic vaginitis patients

Symptomatic patients evaluated in the clinic for vulvovaginal symptoms.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study examine a diagnostic test for vaginal inflammations (vaginitis) which is only applicable to female patients.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with vulvovaginal symptoms

You may qualify if:

  • Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain
  • Age \>= 18y

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit HMO

Jerusalem, Jerusalem, Israel

Location

Related Publications (1)

  • 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.

    PMID: 37055473BACKGROUND

MeSH Terms

Conditions

Vaginosis, BacterialCandidiasis, VulvovaginalTrichomonas VaginitisAtrophic Vaginitis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCandidiasisMycosesVulvovaginitisVulvitisVulvar DiseasesTrichomonas InfectionsProtozoan InfectionsParasitic Diseases

Study Officials

  • Avraham Ben Chetrit, MD

    Clalit HMO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

December 1, 2020

Primary Completion

October 30, 2022

Study Completion

March 30, 2023

Last Updated

May 13, 2025

Record last verified: 2024-11

Locations

IL(1)