Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745155
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-27
First Post:
2023-02-07
Brief Title:
REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
Sponsor:
Senti Tech Ltd
Organization:
Senti Tech Ltd
Study Overview
Official Title:
Senti Remote Evaluation and Monitoring of Acoustic Pathophysiological Parameters With External Sensor Technology - FLAg for Review Efficacy Investigation a Community-based Double-blinded Comparative Pivotal Clinical Efficacy Study to Investigate the Efficacy and Safety of a Novel Intelligent Wearable Medical Device System for the Autonomous Monitoring and Evaluation of Acoustic Pathophysiological Parameters in Order to Determine Clinical Deterioration and Flag Deteriorating Patients for Clinical Review Reducing Time-to-intervention in Respiratory Disease Flareups
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMAPWESTFLARE
Brief Summary:
The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term respiratory conditions flags patients who are beginning to deteriorate for clinical review in order to reduce time-to-intervention in respiratory disease flareups
The main question it aims to answer are
Would the use of the Senti-AI and Senti-Wear Device System reduce time-to-intervention in respiratory disease flareups
Participants will wear the Senti-Wear device up to twice per day as tolerated for 12 weeks The Senti-AI subsystem will generate FLAREs flags for review and these will retrospectively be compared to the standard of care to evaluate whether acting on the FLARES would have reduced time-to-intervention
The main question it aims to answer are
Would the use of the Senti-AI and Senti-Wear Device System reduce time-to-intervention in respiratory disease flareups
Participants will wear the Senti-Wear device up to twice per day as tolerated for 12 weeks The Senti-AI subsystem will generate FLAREs flags for review and these will retrospectively be compared to the standard of care to evaluate whether acting on the FLARES would have reduced time-to-intervention
Detailed Description:
This clinical investigation seeks to establish whether or not the Senti-Wear device system with the Senti-AI subsystem is effective for autonomously monitoring people with long-term respiratory illness with COPD The aim of this autonomous monitoring is to generate flags for review FLARES if the system detects a worsening deterioration in lung sounds which might indicate a worsening respiratory illness
If effective this device system will enable people with long-term respiratory illnesses to receive earlier intervention in disease flare-ups ensuring these patients are on the right medication at the right time avoiding hospital admissions and staying well at home
200 patients with COPD will be recruited The design of this study is comparative All 200 participants will undertake patient-sought care as usual where patients seek medical aid once starting to feel more unwell Over a six-month period we will collect data on what care is sought and when this changes treatment Participants will also use the Senti-Wear device to capture their breath and heart sounds twice a day over this six-month period Participants clinicians and the research team will be blinded to the device output FLARES until the end of the data collection period
At the end of the data collection period we will compare this with Senti-AI FLARES to determine whether acting on FLARES would have led to early intervention in disease flareups
The study activities will take place in the participants own homes The study will recruit around Manchester and Liverpool UK The study is being funded by Senti-Tech limited the manufacturer of the Senti-Wear with Senti-AI device system
If effective this device system will enable people with long-term respiratory illnesses to receive earlier intervention in disease flare-ups ensuring these patients are on the right medication at the right time avoiding hospital admissions and staying well at home
200 patients with COPD will be recruited The design of this study is comparative All 200 participants will undertake patient-sought care as usual where patients seek medical aid once starting to feel more unwell Over a six-month period we will collect data on what care is sought and when this changes treatment Participants will also use the Senti-Wear device to capture their breath and heart sounds twice a day over this six-month period Participants clinicians and the research team will be blinded to the device output FLARES until the end of the data collection period
At the end of the data collection period we will compare this with Senti-AI FLARES to determine whether acting on FLARES would have led to early intervention in disease flareups
The study activities will take place in the participants own homes The study will recruit around Manchester and Liverpool UK The study is being funded by Senti-Tech limited the manufacturer of the Senti-Wear with Senti-AI device system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None