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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01542606
Other study ID # F-7-28.6-1
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2019
Est. completion date December 2019

Study information

Verified date August 2019
Source Common Sense
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

This study was designed to validate the color appearance on the NORMA-SENSE gen 3. The NORMA-SENSE gen 3 changes color when worn by the user and comes into contact with vaginal secretions having an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE gen 3 and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE gen 3 results.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Women, age 18 years or greater with or without symptoms of vaginal infection.

2. Subject is ready to sign the informed consent form.

Exclusion Criteria:

1. Subject is unable or unwilling to cooperate with study procedures.

2. Subject is currently participating in another clinical study.

3. Subject suffers from vaginal bleeding or is menstruating.

4. Subject that have had sexual relations within the last 12 hours.

5. Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.

6. Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Israel Lin Medical Center Clalit health care Haifa

Sponsors (1)

Lead Sponsor Collaborator
Common Sense

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary color status of the NORMA-SENSE gen 3 and the pH measurement. agreement between the color status of the NORMA-SENSE gen 3 as reported by the subject after using the panty liners, and the pH measurement with Nitrazine paper. 3 days
Secondary physical comfort in using NORMA-SENSE gen 3 and the result reading clarity the patient report regarding physical comfort in using NORMA-SENSE gen 3 and the result reading clarity including the ability to visualize and interpret the NORMA-SENSE gen 3 results. 3 days
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