An interventional study of SenseGuard in COPD Exacerbation, sponsored by NanoVation. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by NanoVation · Not applicable, Interventional, and Device feasibility
The study will include daily SenseGuard measurement of patients hospitalized with exacerbations of COPD. from admission to discharge. In parallel clinical evaluation of patient's respiratory condition was done daily by routine tests and questionnaires.
A study for evaluating the feasibility of SenseGuard in assessing the respiratory condition change of hospitalized patients with exacerbation of COPD, by monitoring respiratory parameters. The study duration for each patient will start at the time of enrollment until the patient is released, or until the optional post-discharge follow-up visit.
The study will include at least one visit per day: The visit and measurement with SenseGuard will start prior to the first medical exacerbation treatment effect-onset given on each study day (by inhalation or IV). The measurement with SenseGuard will be done before and after treatment.
At the investigator discretion, additional two similar visits could be performed on the same study day, with or without the admission of the medical exacerbation treatment.
During the study, both the investigator and the patients will be asked to fill questionnaires to assess the patient's condition Additionally, measurements that are performed and collected as a standard practice or at the request of the medical personnel as part of patient's treatment course shall be documented and used as a reference for the study device assessment.
NanoVation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo SG monitoring at least twice daily before and after receiving treatment.
Device: SenseGuard
SG is a wireless, wearable medical device, which includes nano-based sensors. It can seamlessly measure patient's tidal breathing during daily activities. SG extracts series of critical respiratory parameters, including; Respiration Rate (RR), Inhalation and Exhalation duration and ratio (I/E), as well as novel biomarkers. SG parameters are applicable to evaluate COPD patients' condition, or for monitoring patients with other respiratory conditions. SG components are: RSM (Respiratory Sensing Module): non-invasive module with sensors that can detect the exhaled humidity and condensation. The RSM is a non-sterile, disposable, single patient use. ECU (Electronic Control Unit): a re-usable, wireless data acquisition and transmission unit. The ECU is connected to the RSM during the measurement and transmits the data via Bluetooth to the SG software. SenseGuard™ Software: for data management, acquisition, processing, logging and presentation of the digital respiratory signals.
Evaluation of SenseGuard respiratory parameter - Respiratory Rate, in the measurement of clinical change in COPD patients hospitalized with AECOPD
SenseGuard respiratory parameters (Respiratory Rate in BPM ) can be used to assess the changes in respiratory condition of 80% of exacerbated COPD patient, as defined by physician's assessment, patient's self-assessment and/or as measured by current conventional methods.
Time frame: 24 months
Evaluation of SenseGuard respiratory parameter - Inhalation to Exhalation ratio, in the measurement of clinical change in COPD patients hospitalized with AECOPD
SenseGuard respiratory parameters (Inhalation and Exhalation time and ratio) can be used to assess the changes in respiratory condition of 80% of exacerbated COPD patient, as defined by physician's assessment, patient's self-assessment and/or as measured by current conventional methods.
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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