Performance Proof of Product Developed to Detect Abnormal Vaginal pH

Not Applicable

Withdrawn

• Conditions: Vaginal Infection
• Interventions: Device: NORMA-SENSE

• Registration Number: NCT01542606
• Lead Sponsor: Common Sense

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Study Start: 2019-03
• Status Verified: 2019-08
• Primary Completion: 2019-09
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
color status	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.

Primary Outcome Measures

Name	Time	Method
color status of the NORMA-SENSE gen 3 and the pH measurement.	3 days	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.

Secondary Outcome Measures

Name	Time	Method
physical comfort in using NORMA-SENSE gen 3 and the result reading clarity	3 days	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.

Trial Locations

Locations (1)

Lin Medical Center Clalit health care; 🇮🇱 Haifa, Israel