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

NCT07430709 | Not Yet Recruiting FDA Device

• 1 other identifier: STS003
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pulmonary Function Testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Repeatability of STS Measurements in pediatric population

  During study visit

Other Outcomes (1)

• Device-related Adverse Events

  During study visit

Study Arms (1)

STS and Conventional Pulmonary Function Testing

EXPERIMENTAL

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)

Interventions

Spirometry Test System (STS) DEVICE

A handheld device used to measure spirometry parameters and lung volumes including FEV1, FVC, TLC, RV, TGV, airway resistance and respiratory compliance.

STS and Conventional Pulmonary Function Testing

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Technopulm: lead

Central Study Contacts

Shiri Pendler

CONTACT

972548191893; s.pendler@t-pulm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants undergo testing with the STS, and outcomes are assessed through within-subject analysis to determine measurement agreement

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share