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A Study of Sweat Testing Using a Quantitative Patch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01345617
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Polychrome Medical, Inc.

Tracking Information
First Submitted Date April 28, 2011
First Posted Date May 2, 2011
Last Update Posted Date August 29, 2018
Study Start Date January 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2011)
sweat chloride value [ Time Frame: once, at enrollment (baseline) ]
Sweat chloride measurements obtained by GCQPIT and CFQT
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 29, 2011)
QNS rate [ Time Frame: once, at enrollment (baseline) ]
QNS rate of CFQT compared to GCQPIT
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of Sweat Testing Using a Quantitative Patch
Official Title A Study of Sweat Testing Using a Quantitative Patch
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pediatric pulmonology clinic
Condition Cystic Fibrosis
Intervention Not Provided
Study Groups/Cohorts
  • cystic fibrosis patients
    cystic fibrosis patients
  • non-cystic fibrosis patients
    non-cystic fibrosis patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 29, 2011)
170
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Days and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01345617
Other Study ID Numbers 2011-0291
CFQuantum001 ( Other Identifier: PolyChrome Medical, Inc. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Polychrome Medical, Inc.
Original Responsible Party Michael J. Rock, University of Wisconsin
Current Study Sponsor Polychrome Medical, Inc.
Original Study Sponsor University of Wisconsin, Madison
Collaborators Not Provided
Investigators
Principal Investigator: Michael J Rock, MD University of Wisconsin, Madison
PRS Account Polychrome Medical, Inc.
Verification Date August 2018