Pulmonary Function TestingNCT07430709
Validation of the STS Device for Pulmonary Function Test in Pediatric Population
A study testing Spirometry Test System (STS) in people with Pulmonary Function Testing, run by Technopulm.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Pulmonary Function Testing
- What is being tested?
- Spirometry Test System (STS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric subjects aged 7-17 years able to cooperate with testing
- Referred for clinically required pulmonary function testing
- Informed consent obtained from legal guardian
Who cannot join
- Inability to perform lung function testing
- Inability or unwillingness to provide consent
- Presence of tracheostomy
- Pulmonary edema
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Pulmonary Function Testing
- Being tested
- Spirometry Test System (STS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spirometry Test System (STS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During study visit (single session)
Secondary outcomes (1)
Repeatability of STS Measurements in pediatric population
Assessment of repeatability by performing three consecutive STS trials for each participant
Measured: During study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start5 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Function TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants undergo testing with the STS, and outcomes are assessed through within-subject analysis to determine measurement agreement
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technopulm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430709
- Sponsor's protocol ID
- STS003
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the STS Device for the Measurement of Pulmonary Parameters in a Pediatric Population
- ClinicalTrials.gov ID
- NCT07430709
- Acronym / sponsor ID
- STS003
- Conditions
- Pulmonary Function Testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- TechnopulmIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants undergo testing with the STS, and outcomes are assessed through within-subject analysis to determine measurement agreement
| Arm | Type | Receives |
|---|---|---|
| STS and Conventional Pulmonary Function Testing | Experimental | Device: Spirometry Test System (STS)Participants will undergo pulmonary function testing using both the STS handheld device and conventional laboratory spirometry and body plethysmography in randomized order. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric subjects aged 7-17 years able to cooperate with testing
- Referred for clinically required pulmonary function testing
- Informed consent obtained from legal guardian
Key exclusion criteria (4 listed)
- Inability to perform lung function testing
- Inability or unwillingness to provide consent
- Presence of tracheostomy
- Pulmonary edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | STS and Conventional Pulmonary Function Testing |
Primary outcome
Agreement Between STS and Conventional Pulmonary Function Measurements in pediatric population
Time frame: During study visit (single session)
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.
1 secondary outcome
Repeatability of STS Measurements in pediatric population
Time frame: During study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry Test System (STS) in people with Pulmonary Function Testing, run by Technopulm.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiri Pendler (972548191893, s.pendler@t-pulm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between STS and Conventional Pulmonary Function Measurements in pediatric population (time frame: During study visit (single session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.