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Performance Proof of Product Developed to Detect Abnormal Vaginal pH

This study is not yet open for participant recruitment.
Verified November 2011 by Common Sense
Sponsor:
Information provided by (Responsible Party):
Common Sense
ClinicalTrials.gov Identifier:
NCT01542606
First received: February 21, 2012
Last updated: March 1, 2012
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Vaginal Infection
 Device: NORMA-SENSE
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Performance Proof of The Norma-Sense Gen 3 - Wearing Study

Further study details as provided by Common Sense:

Primary Outcome Measures:
  • color status of the NORMA-SENSE gen 3 and the pH measurement. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 256
Study Start Date: March 2012
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542606

Contacts
Contact: Adam Geva, MD 972-4-8568610 adamge@clalit.org.il

Locations
Israel
Lin Medical Center Clalit health care Not yet recruiting
Haifa, Israel
Contact: Adam Geva, MD     972-4-8568910     adamge@clalit.org.il    
Principal Investigator: Adam Geva, MD            
Sponsors and Collaborators
Common Sense
Investigators
Study Director: Hadar Kessary, PhD Common Sense
  More Information

No publications provided

Responsible Party: Common Sense
ClinicalTrials.gov Identifier: NCT01542606     History of Changes
Other Study ID Numbers: F-7-28.6-1
Study First Received: February 21, 2012
Last Updated: March 1, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Common Sense:
PH
SCREENING
EARLY WARNING
 VAGINAL HEALTH
VAGINAL SECRETION
VAGINAL PH

ClinicalTrials.gov processed this record on May 19, 2013