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

Cystic Fibrosis Clinical Trial

Official title:

A Multi-Center Study of A New Method of Sweat Testing: The CF Quantum® Sweat Test

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02404714
• Other study ID #: CFQuantum003
• Status: Terminated
• Start date: February 8, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2018
• Source: Polychrome Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The primary objective is to evaluate the diagnostic accuracy of a new sweat test method in both normal individuals and individuals with CF or cystic fibrosis related metabolic syndrome (CRMS).

Subject participation is for one day and duration of study for each subject is one day. No follow-up will be required.

Number of subjects; 300 split evenly between subjects with previously diagnosed CF or CRMS (cystic fibrosis related metabolic syndrome) and subjects referred to the sweat test lab for clinical reasons.

Number of sites = 6, U of WI-Madison, U of WI-Milwaukee, U of MI-Ann Arbor, Dayton Children's Hospital (OH), U of MN, and Children's of Alabama.

Primary endpoints:

• Clinical and analytical sensitivity of the new test method

• Clinical and analytical sensitivity of the standard-of-care methods

Statistics Sensitivity and specificity will be calculated and reported along with the corresponding 95% confidence intervals. Bias assessment will be conducted according to the Clinical and Laboratory Standards Institute (CLSI) guidelines for method comparison and bias estimation. Pearson's correlation analysis will be conducted to test for adequate range of the replicate values for the new test method.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients referred to the sweat test lab on a clinical basis.

2. Infants who require a sweat test as follow-up to an abnormal CF screening test.

3. Patients who have already been diagnosed with CF or CRMS.

4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.

Exclusion Criteria:

1. Patient is receiving oxygen by open delivery.

2. Infants less than 48 hours of age.

3. Diffuse inflammation or rash on the collection site.

4. Patients who have had a reaction to a prior iontophoretic sweat test procedure.

5. Arm is too small for both the new and conventional sweat test.

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan-Ann Arbor, Cystic Fibrosis Center	Ann Arbor	Michigan
United States	Children's Hospital of Alabama at UAB	Birmingham	Alabama
United States	Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Dayton Children's Hospital	Dayton	Ohio
United States	University of Wisconsin-Madison CF Center	Madison	Wisconsin
United States	University of Minnesota Masonic Children's Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Polychrome Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity and specificity (true positive rate and the false negative rate to measure chloride in the sweat sample) of the new sweat test device compared to the standard-of-care sweat test device		Day 1
Secondary	Compare the sweat test's "quantity not sufficient" (QNS) rate of the new device to the standard-of-care device.		Day 1