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A Multi-Center Study of the CF Quantum® Sweat Test System

NCT02404714 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2018-08-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Iontophoresis sweat test

The intervention is iontophoretic sweat testing which includes the stimulation, collection and analysis of sweat. The standard of care sweat testing used at each institution will be compared to a new iontophoresis sweat test called the CF Quantum.

Sponsors & Collaborators

  • Polychrome Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Rock, MD · University of Wisconsin, Madison

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2018-07-01
Completion
2018-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02404714 on ClinicalTrials.gov