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A Study of Sweat Testing Using a Quantitative Patch

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ClinicalTrials.gov Identifier: NCT01345617
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
Polychrome Medical, Inc.

Brief Summary:
The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing. The secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum Sweat Test compared to traditional sweat testing.

Condition or disease
Cystic Fibrosis

Detailed Description:
All 50 states and the District of Columbia are performing newborn screening for cystic fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This test has many difficulties including specimens that are quantity not sufficient (QNS), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. The only manufacturer of a chloridometer has ceased production of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are equivalent to GCQPIT.

Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Study of Sweat Testing Using a Quantitative Patch
Study Start Date : January 2012
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
cystic fibrosis patients
cystic fibrosis patients
non-cystic fibrosis patients
non-cystic fibrosis patients



Primary Outcome Measures :
  1. sweat chloride value [ Time Frame: once, at enrollment (baseline) ]
    Sweat chloride measurements obtained by GCQPIT and CFQT


Secondary Outcome Measures :
  1. QNS rate [ Time Frame: once, at enrollment (baseline) ]
    QNS rate of CFQT compared to GCQPIT



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric pulmonology clinic
Criteria

Inclusion Criteria:

  • clinical diagnosis of cystic fibrosis
  • patients who require a sweat test

Exclusion Criteria:

  • Infants less than 48 hours of age
  • Patient is receiving oxygen by open delivery
  • collection site has diffuse inflammation or rash

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): NCT01345617


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84012
United States, Wisconsin
American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Polychrome Medical, Inc.
Investigators
Principal Investigator: Michael J Rock, MD University of Wisconsin, Madison

Responsible Party: Polychrome Medical, Inc.
ClinicalTrials.gov Identifier: NCT01345617     History of Changes
Other Study ID Numbers: 2011-0291
CFQuantum001 ( Other Identifier: PolyChrome Medical, Inc. )
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases