NCT05119374Completed
Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD.
Clinical Evaluation of the Capability of SenseGuard™ Non-invasive Wearable Device, to Detect Respiratory Changes, During Home Monitoring of Subjects With High Susceptibility for Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Source: ClinicalTrials.gov · Last updated 26 Mar 2024
Brief summary (registry, in English)
This is an observational, open labeled study. The study aims to evaluate the capability of SenseGuard™ (SG) non-invasive wearable device, to detect, post-hoc, early respiratory changes due to exacerbation by daily monitoring of subjects with COPD, at home. Subjects with COPD, that were discharged following hospitalization due to AECOPD are most susceptible to experience another exacerbation during the first 6 months post admission. Hence, subjects that were discharged from the hospital due to AECOPD during the last 3 months are eligible to the study.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 3 Nov 2021
- Start date
- 11 Nov 2021
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- NanoVation
- Diseases
- COPD
- NCT number
- NCT05119374
What you commit to
- Study type: Interventional
- Participants enrolled: 57
- From 11 Nov 2021 to the primary completion date, 28 Feb 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Suffer from any physical or cognitive impairment that may affect subject's capability to operate the SG device properly.
- Suffering from serious uncontrolled medical conditions that may interfere with study requirements.
Other
- Pregnant woman or nursing mother.
- Severely ill with less than 12-month life expectancy
- Participated in another clinical study during the study period, that may interrupt their participation in this study.
Who the study is looking for
- Male or female, aged ≥18.
- Diagnosed with COPD, 30%\< FEV1 \<80% predicated, or FEV1\>80% and FEV1/FVC \< 0.7
- Discharged from the hospital during the last 3 months due to AECOPD.
- Provision of signed and dated informed consent form.
- Speak, read and understand either Hebrew, Arabic or English.
- Able to understand study requirements and comply with study procedures.
- Able to operate a tablet for SG measurement.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Barzilai University Medical Center Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| Bnai Zion Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Nazareth Hospital E.M.M.S Coordinator of this site? Confirm its status | Nazareth | Israel | Unknown status |
| Tel Aviv Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| The Institute of Pulmonology Baruch Padeh Medical Center Coordinator of this site? Confirm its status | Tiberias | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.