Clinical Trials Logo
  1. Home
  2. Bacterial Vaginosis
  3. NCT04219605
  4. Details
NCT04219605 Clinical Trial

Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Bacterial Vaginosis Clinical Trial

Official title:
Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04219605
Other study ID # 0120-19-COM1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 2023

Study information
Verified date March 2023
Source Meir Medical Center
Contact Ahinoam Lev-Sagie, MD
Phone 972-2-5889551
Email levsagie@netvision.net.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections). One additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud. The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain - Age >= 18y Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Clalit HMO Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic performance Specificity and sensitivity of the device performance in regard to vaginitis conditions 12 months
See also
  Status Clinical Trial Phase
Completed NCT03930745 - Suppression Of Bacterial Vaginosis (BV) [SUBVert] Phase 2
Completed NCT02863536 - A Study of the New Medical Device Polybactum® N/A
Completed NCT03187457 - PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?" N/A
Recruiting NCT02185456 - Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis Phase 0
Completed NCT02150655 - Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women Phase 0
Completed NCT01450462 - Vitamin D and Sexual Health N/A
Recruiting NCT01558388 - Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy Phase 4
Completed NCT01471457 - Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis Phase 2/Phase 3
Not yet recruiting NCT00889356 - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis Phase 3
Completed NCT00545181 - Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial N/A
Completed NCT00556179 - Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis Phase 4
Completed NCT02236156 - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) Phase 3
Not yet recruiting NCT05434104 - The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study N/A
Completed NCT01335373 - Observational Program Neo-Penotran® Forte N/A
Completed NCT00752193 - Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System. N/A
Active, not recruiting NCT00536848 - The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients Phase 2/Phase 3
Completed NCT00510614 - Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study Phase 0
Suspended NCT00207480 - Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women Phase 1
Recruiting NCT05278130 - Serial Screening and Treatment of Bacterial Vaginosis Trial N/A
Completed NCT02905890 - The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis Phase 4