NCT05745155Completed
REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 7 Feb 2023
- Start date
- May 2023
- Primary completion date
- Apr 2024
- Lead sponsor
- Senti Tech Ltd
- Diseases
- COPD
- NCT number
- NCT05745155
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From May 2023 to the primary completion date, Apr 2024
- 1 site 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
- Participants with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own Activities of Daily Living; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
- Participants with a known sensitivity or allergy to any of the components of the device.
Age
- Participants under the age of 18.
Other
- Participants with existing pressure sores across the thorax and/or torso.
- Participants with a height outside the range (150-189cm)
- Participants with a waist circumference outside the range (62-169cm)
- Participants unable to give their consent.
Who the study is looking for
- Diagnosis of COPD (on GP record is acceptable) and at least one COPD exacerbation requiring steroid prescription in the last three years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Senti Tech Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.