A Study of Sweat Testing Using a Quantitative Patch

Cystic Fibrosis Clinical Trial

Official title:

A Study of Sweat Testing Using a Quantitative Patch

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345617
• Other study ID #: 2011-0291
• Secondary ID: CFQuantum001
• Status: Completed
• Start date: January 2012
• Est. completion date: October 2013

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis

Locations

Country	Name	City	State
United States	American Family Children's Hospital	Madison	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Utah	Salt Lake City	Utah

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	sweat chloride value	Sweat chloride measurements obtained by GCQPIT and CFQT	once, at enrollment (baseline)
Secondary	QNS rate	QNS rate of CFQT compared to GCQPIT	once, at enrollment (baseline)