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Performance Proof of Product Developed to Detect Abnormal Vaginal pH

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ClinicalTrials.gov Identifier: NCT01542606
Recruitment Status : Unknown
Verified November 2011 by Common Sense.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2012
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Vaginal Infection Device: NORMA-SENSE Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Performance Proof of The Norma-Sense Gen 3 - Wearing Study
Study Start Date : March 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : November 2012

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.



Primary Outcome Measures :
  1. color status of the NORMA-SENSE gen 3 and the pH measurement. [ Time Frame: 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 :
  1. physical comfort in using NORMA-SENSE gen 3 and the result reading clarity [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Common Sense
ClinicalTrials.gov Identifier: NCT01542606     History of Changes
Other Study ID Numbers: F-7-28.6-1
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: November 2011

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