Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD.

NACompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

November 11, 2021

Primary Completion Date

February 28, 2024

Study Completion Date

February 28, 2024

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
DEVICE

SenseGuard Investigational Device

"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."

Trial Locations (6)

Unknown

The Barzilai University Medical Center, Ashkelon

Bnai Zion Medical Center, Haifa

Rambam Health Campus, Haifa

Nazareth Hospital E.M.M.S, Nazareth

Tel Aviv Medical Center, Tel Aviv

The Institute of Pulmonology Baruch Padeh Medical Center, Tiberias

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NanoVation

INDUSTRY

NCT05119374 - Clinical Evaluation of SenseGuard™ to Detect Respiratory Changes, During Home Monitoring of Subjects With High Risk of AECOPD. | Biotech Hunter | Biotech Hunter