Performance Proof of Product Developed to Detect Abnormal Vaginal pH

Vaginal Infection Clinical Trial

Official title:

Performance Proof of The Norma-Sense Gen 3 - Wearing Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01542606
• Other study ID #: F-7-28.6-1
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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.

Related Conditions & MeSH terms

• Vaginal Infection

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