A Multi-Center Study of the CF Quantum® Sweat Test System
Stopped early
Conditions studied: Cystic Fibrosis
In brief
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System. The results of the new device in this study are for comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.
Key facts
- Study ID
- NCT02404714
- Run by
- Polychrome Medical, Inc.
- People needed
- 55
- Starts
- 2017-02-08
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2018-08-31
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients referred to the sweat test lab on a clinical basis.
- Infants who require a sweat test as follow-up to an abnormal CF screening test.
- Patients who have already been diagnosed with CF or CRMS.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
You may not qualify if…
- Patient is receiving oxygen by open delivery.
- Infants less than 48 hours of age.
- Diffuse inflammation or rash on the collection site.
- Patients who have had a reaction to a prior iontophoretic sweat test procedure.
- Arm is too small for both the new and conventional sweat test.
Where it is running
- Children's Hospital of Alabama at UAB — Birmingham, Alabama, United States
- Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- University of Michigan-Ann Arbor, Cystic Fibrosis Center — Ann Arbor, Michigan, United States
- University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
- Dayton Children's Hospital — Dayton, Ohio, United States
- University of Wisconsin-Madison CF Center — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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