IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
A Study of Sweat Testing Using a Quantitative Patch
This study has been completed.
Sponsor:
Polychrome Medical, Inc.
Information provided by (Responsible Party):
Polychrome Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01345617
First received: April 28, 2011
Last updated: November 14, 2013
Last verified: November 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
| Cystic Fibrosis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Study of Sweat Testing Using a Quantitative Patch |
Resource links provided by NLM:
Further study details as provided by Polychrome Medical, Inc.:
Primary Outcome Measures:
- sweat chloride value [ Time Frame: once, at enrollment (baseline) ]Sweat chloride measurements obtained by GCQPIT and CFQT
Secondary Outcome Measures:
- QNS rate [ Time Frame: once, at enrollment (baseline) ]QNS rate of CFQT compared to GCQPIT
| Enrollment: | 170 |
| Study Start Date: | January 2012 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
cystic fibrosis patients
cystic fibrosis patients
|
|
non-cystic fibrosis patients
non-cystic fibrosis patients
|
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.
Eligibility| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345617
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | Polychrome Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT01345617 History of Changes |
| Other Study ID Numbers: |
2011-0291 CFQuantum001 ( Other Identifier: PolyChrome Medical, Inc. ) |
| Study First Received: | April 28, 2011 |
| Last Updated: | November 14, 2013 |
Additional relevant MeSH terms:
|
Cystic Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on September 21, 2017