Performance Proof of Product Developed to Detect Abnormal Vaginal pH

Sponsor

Common Sense (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01542606

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Vaginal Infection	Device: NORMA-SENSE	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: color status 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.	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.

Arm

Intervention/Treatment

Experimental: color status

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.

Device: NORMA-SENSE

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women, age 18 years or greater with or without symptoms of vaginal infection.
Subject is ready to sign the informed consent form.

Exclusion Criteria:

Subject is unable or unwilling to cooperate with study procedures.
Subject is currently participating in another clinical study.
Subject suffers from vaginal bleeding or is menstruating.
Subject that have had sexual relations within the last 12 hours.
Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lin Medical Center Clalit health care	Haifa		Israel

Sponsors and Collaborators

Common Sense

Investigators

Study Director: Hadar Kessary, PhD, Common Sense

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Common Sense

ClinicalTrials.gov Identifier:

NCT01542606

Other Study ID Numbers:

F-7-28.6-1

First Posted:

Mar 2, 2012

Last Update Posted:

Oct 31, 2019

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Common Sense

Study Results

No Results Posted as of Oct 31, 2019