Clinical Research Directory
Browse clinical research sites, groups, and studies.
Validation of the STS Device for Pulmonary Function Test in Pediatric Population
Sponsor: Technopulm
Summary
This prospective, single-arm, self-controlled validation study aims to evaluate the accuracy and safety of the Spirometry Test System (STS) handheld device in measuring pulmonary parameters in pediatric subjects aged 7-17 years. Each participant will undergo pulmonary function testing using both conventional laboratory methods (spirometry and body plethysmography) and the STS device in randomized order. Agreement between methods, repeatability of measurements, and device safety will be assessed. The study will be conducted at Children's National Hospital, Washington, USA
Official title: Evaluation of the STS Device for the Measurement of Pulmonary Parameters in a Pediatric Population
Key Details
Gender
All
Age Range
7 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-03-05
Completion Date
2026-12-31
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
Spirometry Test System (STS)
A handheld device used to measure spirometry parameters and lung volumes including FEV1, FVC, TLC, RV, TGV, airway resistance and respiratory compliance.