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Performance Proof of Product Developed to Detect Abnormal Vaginal pH

NCT01542606 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-10-31

No results posted yet for this study

Summary

This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level

Conditions

  • Vaginal Infection

Interventions

DEVICE

NORMA-SENSE

The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test.

Sponsors & Collaborators

  • Common Sense

    lead OTHER

Principal Investigators

  • Hadar Kessary, PhD · Common Sense

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2019-09-30
Completion
2019-12-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542606 on ClinicalTrials.gov