Clinical Trial

Validation of the STS Device for Pulmonary Function Test in Pediatric Population

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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
Trial Details
NCT Number NCT07430709
Lead Sponsor Technopulm
Conditions Pulmonary Function Testing
Enrollment 160 participants
Start Date 2026-03-05
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-24