MedDataX Logo

A Study of Sweat Testing Using a Quantitative Patch

NCT ID: NCT01345617

Last Updated: 2018-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02404714

Cystic Fibrosis
TERMINATED

Sweat Testing in Infants: Comparing Sweat Collection on Upper Vs Lower Limbs

NCT06902363

Cystic Fibrosis (CF)
NOT_YET_RECRUITING NA

Comparing Chest Images From MRI to CT in Patients With Cystic Fibrosis (CF)

NCT01860872

Cystic Fibrosis
COMPLETED

Evaluating Sensations of Breathlessness in Patients With Cystic Fibrosis

NCT01799642

Lung; Disease Cystic Fibrosis Healthy
COMPLETED

Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis

NCT06836453

Cystic Fibrosis
RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cystic fibrosis patients

cystic fibrosis patients

No interventions assigned to this group

non-cystic fibrosis patients

non-cystic fibrosis patients

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Polychrome Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael J Rock, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

American Family Children's Hospital

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CFQuantum001

Identifier Type: OTHER

Identifier Source: secondary_id

2011-0291

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sweat Response, Sweat Composition and Thermoregulatory Response to Exercise in Heat in Adults With Cystic Fibrosis on Modulator Therapy.
NCT05896488 UNKNOWN
Implementation of a Non-invasive Version of the Imaging β-adrenergic-dependent Sweat Secretion Test
NCT03584841 UNKNOWN NA
Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
NCT03913507 COMPLETED NA
Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)
NCT05998629 RECRUITING NA
Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis
NCT05239611 COMPLETED PHASE2
Sweat Evaporimeter Measurement
NCT01708655 COMPLETED NA
A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor
NCT03367494 TERMINATED NA
CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
NCT03350828 ACTIVE_NOT_RECRUITING
Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
NCT00006273 UNKNOWN
Exercise-Induced Bronchospasm in Cystic Fibrosis
NCT00806455 COMPLETED
CF Bronchodilation
NCT03522831 ACTIVE_NOT_RECRUITING NA
Timing of Hypertonic Saline Inhalation Relative to Airways Clearance in Cystic Fibrosis
NCT01753869 TERMINATED NA
Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults
NCT02368080 COMPLETED
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
NCT04058548 COMPLETED NA
Cystic Fibrosis Core Strengthening and Respiratory Exercise Program
NCT00751647 COMPLETED PHASE2
Muscle Fatigue in People With Cystic Fibrosis: Insight From a Mobile App
NCT07135869 RECRUITING
6 Minute Walk Test in Cystic Fibrosis
NCT02538575 COMPLETED NA
Near Patient Microbial Testing in Cystic Fibrosis
NCT01877707 COMPLETED NA
Airway Secretion Clearance in Cystic Fibrosis
NCT00839644 TERMINATED NA
Effects of Training Intensity on Physical Fitness and Body Composition in Cystic Fibrosis
NCT05140967 COMPLETED NA
A CFit Study - Acute Exercise
NCT03237767 TERMINATED NA
Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis
NCT00721071 COMPLETED PHASE2
A CFit Study - Baseline
NCT03234387 TERMINATED
Parameters to Assess Response to Intra-Venous Antibiotic Treatment for Pulmonary Exacerbations in Cystic Fibrosis
NCT04016571 COMPLETED
Evaluating the Impact of Chronic Rhinosinusitis on the Health-Related Quality of Life Among Adults With Cystic Fibrosis
NCT02003079 COMPLETED