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A Study of Sweat Testing Using a Quantitative Patch

Sponsor
Polychrome Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01345617
Collaborator
(none)
170
Enrollment
3
Locations
21
Duration (Months)
56.7
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jan 1, 2012
    Actual Primary Completion Date :
    Oct 1, 2013
    Actual Study Completion Date :
    Oct 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    cystic fibrosis patients

    cystic fibrosis patients
    non-cystic fibrosis patients

    non-cystic fibrosis patients

    Outcome Measures

    Primary Outcome Measures

    1. sweat chloride value [once, at enrollment (baseline)]

      Sweat chloride measurements obtained by GCQPIT and CFQT

    Secondary Outcome Measures

    1. QNS rate [once, at enrollment (baseline)]

      QNS rate of CFQT compared to GCQPIT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Days and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55455
    2 University of Utah Salt Lake City Utah United States 84012
    3 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Polychrome Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT01345617
    Other Study ID Numbers:
    • 2011-0291
    • CFQuantum001
    First Posted:
    May 2, 2011
    Last Update Posted:
    Aug 29, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Cystic Fibrosis

    Study Results

    No Results Posted as of Aug 29, 2018