CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 579 enrolled
Drug / intervention
Resmon PRO FULL v2device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04006964
NCT04006964N/ACompleted

Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies

Restech Srl·observational·Posted Jul 5, 2019·Updated Nov 3, 2022

In Brief

An observational study evaluating Resmon PRO FULL v2 for Respiratory Disease. Completed, enrolled 579 participants across 6 sites in 2 countries.

Detailed Summary

The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing, requiring minimal patient cooperation. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly, United States
CollaboratorsMGC Diagnostics

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 5, 2019
Enrollment StartOct 18, 2018
Primary CompletionJun 26, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.0 years ago

Interventions

Resmon PRO FULL v2device

Measurement of lung impedance by the Forced Oscillation Technique