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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

February 21, 2012
March 1, 2012
March 2012
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01542606 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Performance Proof of Product Developed to Detect Abnormal Vaginal pH
Performance Proof of The Norma-Sense Gen 3 - Wearing Study

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

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.
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Vaginal Infection
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.
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.
Intervention: Device: NORMA-SENSE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
256
November 2012
September 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 65 Years
Yes
Contact: Adam Geva, MD 972-4-8568610 adamge@clalit.org.il
Israel
 
NCT01542606
F-7-28.6-1
Yes
Common Sense
Common Sense
Not Provided
Study Director: Hadar Kessary, PhD Common Sense
Common Sense
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP