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

Evaluation of the STS Device for the Measurement of Pulmonary Parameters in a Pediatric Population

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Function Testing
• Intervention / Treatment: Device: Spirometry Test System (STS)

Detailed Description

Pulmonary function testing (PFT) is essential for diagnosing and monitoring respiratory diseases in pediatric patients. Conventional PFT requires body plethysmography and laboratory spirometry, which can be time-consuming and challenging for children.

The Spirometry Test System (STS) is a portable handheld device capable of measuring spirometry parameters and lung volumes without the need for a plethysmograph chamber. The STS device is FDA cleared for use in adult patients (FDA 510(k) K240293). However, its performance has not yet been validated in the pediatric population.

This study aims to evaluate the accuracy and safety of the STS device in pediatric subjects aged 7-17 years.

Pediatric patients referred for clinically required pulmonary function testing will perform lung function testing using both conventional laboratory methods (spirometry and body plethysmography) and the STS device. The testing order will be randomized to minimize order bias. Each test will be performed by a different technician, and technicians will remain blinded to the results of the alternate testing method.

The primary objective is to evaluate agreement between STS measurements and conventional pulmonary function testing using Bland-Altman analysis. Secondary objectives include assessment of repeatability and safety evaluation.

The first 10 enrolled subjects will serve as an initial training set and will not be included in the final analysis. Interim analyses will be performed periodically throughout the study to ensure data quality and safety oversight.

The study involves a single visit and no follow-up assessments.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiri Pendler; Phone Number: 972548191893; Email: s.pendler@t-pulm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric subjects aged 7-17 years able to cooperate with testing
• Referred for clinically required pulmonary function testing
• Informed consent obtained from legal guardian

Exclusion Criteria:

• Inability to perform lung function testing
• Inability or unwillingness to provide consent
• Presence of tracheostomy
• Pulmonary edema

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STS and Conventional Pulmonary Function Testing; Participants will undergo pulmonary function testing using both the STS handheld device and conventional laboratory spirometry and body plethysmography in randomized order.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Between STS and Conventional Pulmonary Function Measurements in pediatric population	Agreement between measurements obtained using the STS device and conventional pulmonary function tests for spirometry parameters, lung volumes, airway resistance, and lung compliance using Bland-Altman analysis.	During study visit (single session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeatability of STS Measurements in pediatric population	Assessment of repeatability by performing three consecutive STS trials for each participant	During study visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-related Adverse Events	Recording of any adverse events occurring during the STS test	During study visit

Collaborators and Investigators

• Sponsor: Technopulm

Study record dates

Study Major Dates

• Study Start (Estimated): March 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STS003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No