Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432920
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2024-05-17
Brief Title:
A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD a First-in-human Exploratory Study
Sponsor:
Elevre Medical Ltd
Organization:
Elevre Medical Ltd
Study Overview
Official Title:
A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD a First-in-human Exploratory Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
ResWave
Brief Summary:
The goal of this exploratory clinical trial is to evaluate the initial clinical safety and performance of a prototype wearable chest wall vibration CWV device intended to relieve exertional dyspnea in adults with Chronic Obstructive Pulmonary Disease The main questions it aims to answer are
Can CWV be delivered safely to participants via a wearable device
Is there evidence of an effect on participant-reported dyspnea endurance time and other measures of cardiorespiratory function
Participants will undergo two cycle-ergometer exercise testing sessions while wearing the prototype wearable device The device will be active in one session intervention and inactive in the other control The order in which intervention or control occurs will be randomised Researchers gather data relating to adverse events device deficiencies participant-reported symptom severity endurance time and measures of cardiorespiratory function recorded via standard CPET apparatus
Can CWV be delivered safely to participants via a wearable device
Is there evidence of an effect on participant-reported dyspnea endurance time and other measures of cardiorespiratory function
Participants will undergo two cycle-ergometer exercise testing sessions while wearing the prototype wearable device The device will be active in one session intervention and inactive in the other control The order in which intervention or control occurs will be randomised Researchers gather data relating to adverse events device deficiencies participant-reported symptom severity endurance time and measures of cardiorespiratory function recorded via standard CPET apparatus
Detailed Description:
The purpose of this Clinical Investigation is to evaluate the device design in a small number of human subjects with respect to initial clinical safety and to gather preliminary data regarding the effect of the device on patient reported dyspnoea and physiological measures of cardiorespiratory function This will facilitate planning of further steps of device development and validation guide design modifications and define parameters for a future pivotal clinical investigation
The investigational device is at Pilot stage of Clinical Development and the proposed Clinical investigation is a first-in-human exploratory study It is not a superiority non-inferiority or equivalence study
The primary objective of this Clinical Investigation is to evaluate the investigational device with respect to initial clinical safety when used by subjects with Chronic Obstructive Pulmonary Disease during physical exertion in the form of cycle ergometer-based Cardiopulmonary Exercise Testing
The secondary objective of this Clinical Investigation is to gather preliminary data regarding the effect of the device on patient-reported dyspnoea and physiological measures of cardiorespiratory function
Each subject will attend the investigation site for a Pre-Study visit during which formal written consent will be obtained clinical history and medications will be reviewed as part of standard CPET pre-assessment and enrolment in the Clinical Investigation will be complete
An initial Incremental Cardiopulmonary Exercise Testing CPET session will then be conducted to determine baseline Peak Work Rate capacity This is necessary so that the intensity of CPET that will be required to achieve 75 of each subjects individual Peak Work Rate capacity can be determined Peak Work Rate capacity will be defined as the highest work rate that the Subject is able to maintain for 30 seconds
Following initial CPET subjects will return for device testing on a non-consecutive day Each subject will undergo 2 study arms during this visit the Intervention ResWave and Control arms in the random order Both arms will be conducted on the same day with a recovery period of 60 minutes between each arm Subjects will undergo sub-maximal exercise testing at a Constant Work Rate CWR of 75 of their peak work rate capacity in both arms Borg CR10 scores will be recorded at 2 minute intervals throughout Endurance time will be recorded at test completion Adverse Events will be recorded throughout testing and at 72-hour follow-up via phone call Device Deficiencies will be recorded throughout testing
The investigational device is at Pilot stage of Clinical Development and the proposed Clinical investigation is a first-in-human exploratory study It is not a superiority non-inferiority or equivalence study
The primary objective of this Clinical Investigation is to evaluate the investigational device with respect to initial clinical safety when used by subjects with Chronic Obstructive Pulmonary Disease during physical exertion in the form of cycle ergometer-based Cardiopulmonary Exercise Testing
The secondary objective of this Clinical Investigation is to gather preliminary data regarding the effect of the device on patient-reported dyspnoea and physiological measures of cardiorespiratory function
Each subject will attend the investigation site for a Pre-Study visit during which formal written consent will be obtained clinical history and medications will be reviewed as part of standard CPET pre-assessment and enrolment in the Clinical Investigation will be complete
An initial Incremental Cardiopulmonary Exercise Testing CPET session will then be conducted to determine baseline Peak Work Rate capacity This is necessary so that the intensity of CPET that will be required to achieve 75 of each subjects individual Peak Work Rate capacity can be determined Peak Work Rate capacity will be defined as the highest work rate that the Subject is able to maintain for 30 seconds
Following initial CPET subjects will return for device testing on a non-consecutive day Each subject will undergo 2 study arms during this visit the Intervention ResWave and Control arms in the random order Both arms will be conducted on the same day with a recovery period of 60 minutes between each arm Subjects will undergo sub-maximal exercise testing at a Constant Work Rate CWR of 75 of their peak work rate capacity in both arms Borg CR10 scores will be recorded at 2 minute intervals throughout Endurance time will be recorded at test completion Adverse Events will be recorded throughout testing and at 72-hour follow-up via phone call Device Deficiencies will be recorded throughout testing
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