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A Feasibility Study of Evaluation of SenseGuard, Non-Invasive Wearable Device, in Assessing Respiratory Condition Change of Patients With Exacerbation of Chronic Obstructive Pulmonary Disease
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Universitätsklinikum Halle (Saale) Universitätsklinik und Poliklinik für Innere Medizin I
Halle, Germany
Galilee Medical Center
Nahariya, Israel
Start Date
August 11, 2020
Primary Completion Date
May 25, 2022
Completion Date
May 25, 2023
Last Updated
March 26, 2024
15
ACTUAL participants
SenseGuard
DEVICE
Lead Sponsor
NanoVation
NCT07351929
NCT05958563
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06347536