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NCT04006964 · ClinicalTrials.gov registry record
Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies
A clinical trial of Respiratory Disease, sponsored by Restech Srl.
- Completed
- Registry status
- 579
- Enrollment target
- 6
- Study locations
NCT04006964: Completed study of Respiratory Disease, sponsored by Restech Srl.
NCT04006964 is a study of Respiratory Disease that has completed, run by Restech Srl. The registered enrollment target is 579 participants, above the 232-participant average among 7 other Respiratory Disease trials with a reported enrollment target (150% higher). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04006964, a study of Respiratory Disease, has completed, sponsored by Restech Srl.
- COMPLETED
- Registry status
- 579 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
This will be a rule to detect lung anomalies as compared with spirometry that will be identified and validated in two separate populations
Conditions Studied
Interventions
- DEVICE Resmon PRO FULL v2
Study Locations (6)
Other
- ASST Papa Giovanni XXIII - Bergamo
- Istituto di Biomedicina e Immunologia Molecolare "A. Monroy" - Palermo
California
- Biomedical Research Institute at Harbor- UCLA Medical Center - Los Angeles
Vermont
- University of Vermont Medical Center Inc., - Burlington
FI
- Azienda Ospedaliero, Universitaria Meyer - Florence
Lazio
- Catholic University of the Sacred Heart - Rome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2018-10-18 |
| Est. Completion | 2022-06-26 |
What the finished NCT04006964 record still lists
NCT04006964 is an observational study that tracks outcomes without assigning an intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap, above the 232-participant average among 7 other Respiratory Disease trials with a reported enrollment target (150% higher).
The record links to 1 condition, with Respiratory Disease appearing as the primary indexed condition, and to 1 intervention - of which Resmon PRO FULL v2 is the first listed.
NCT04006964 lists 6 locations in 5 states (Other, California, Vermont).
Frequently Asked Questions
What is clinical trial NCT04006964 about?
NCT04006964 is a clinical study titled "Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies". 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) ...
What is the current status of trial NCT04006964?
This trial is currently completed. The enrollment target is 579 participants. The study started on 2018-10-18. Estimated completion is 2022-06-26.
What conditions does trial NCT04006964 study?
This clinical trial studies the following conditions: Respiratory Disease.
What interventions are being tested in trial NCT04006964?
The interventions under investigation include: Resmon PRO FULL v2 (DEVICE).
Who is sponsoring clinical trial NCT04006964?
This trial is sponsored by Restech Srl, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04006964 being conducted?
This trial has 6 study locations across California, Vermont, FI, Lazio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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