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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06432920
Other study ID # RW-CIP 1.2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 6, 2023
Est. completion date January 26, 2024

Study information

Verified date May 2024
Source Elevre Medical Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 subject's 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 26, 2024
Est. primary completion date January 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with FEV1 / FVC ratio of < 75% and deemed clinically stable - Moderate to severe airflow limitation on Spirometry (FEV1: 30 to 75% predicted) - Pulmonary Function Testing completed in the last 6 months Exclusion Criteria: - Active pulmonary infection or exacerbation within last 6 weeks - Unstable cardiac disease - cardiac intervention, change in symptoms or medication within last 6 weeks - BMI > 35 - Receiving domiciliary oxygen therapy - Diagnosis of COVID-19 within the last 12 weeks or persistent symptoms directly attributable to previous COVID-19 infection - Presence of comorbid condition that is deemed to be a significant contributor to dyspnoea: Heart Failure, Chronic Thromboembolic Disease, Neuromuscular Disease, Primary Pulmonary Hypertension - Pulmonary Embolism in last 3 months - Abdominal or Thoracic surgery in last 3 months - Pneumothorax in last 6 months - Active malignancy - Active chest wall pain, active skin condition or open wound on thorax - Pregnant or breastfeeding - Women of child-bearing age (premenopausal, under age 50, or without previous sterilisation surgery) - Any implantable electronic device - On anticoagulants or with known history of coagulopathy - Any absolute or relative contraindication to CPET testing - Disability or comorbid condition that prevents exercise training and/or use of CPET apparatus and/or wearing the investigational device - Previous experience of Chest Wall Vibration therapies for relief of breathlessness - Currently enrolled in any other clinical trial or research study - People deemed to be incapable of giving consent, or with reduced capacity to consent or diminished autonomy as a result of mental or cognitive impairment, or deemed otherwise vulnerable on clinical grounds

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ResWave
Prototype wearable in-phase chest wall vibration device

Locations

Country Name City State
Ireland Beacon Hospital Sandyford Dublin 18

Sponsors (2)

Lead Sponsor Collaborator
Elevre Medical Ltd. Beacon Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events Adverse Events during or following use of the prototype device and/or exercise testing protocol 72 hours
Primary Device Deficiencies Performance data of the device during use During active use in exercise testing
Secondary Dyspnea severity Borg Category-Ratio scale (Borg CR10). Scale from 0 (lowest intensity, better) to 10 (maximal intensity, worse). Recorded at 2 minute intervals during exercise testing. Outcome measure at isotime.
Secondary Endurance time Exercise testing endurance time Duration of exercise testing
Secondary Reason for stopping Whether participant stopped exercise testing due to dyspnea or other reason During exercise testing
Secondary Minute Ventilation (VE) Minute Ventilation in millilitres/minute (mL/min) During exercise testing
Secondary Heart Rate (HR) Heart rate in beats per minute (BPM) During exercise testing
Secondary Oxygen Pulse Oxygen Pulse (VO2/HR) in millilitres/minute (mL/min) During exercise testing
Secondary Oxygen Consumption Oxygen Consumption (VO2) in millilitres/minute (mL/min) During exercise testing
Secondary Carbon Dioxide Production Carbon Dioxide Production (VCO2) in millilitres/minute (mL/min) During exercise testing
Secondary Work Work (W) in watts During exercise testing
Secondary Tidal Volume (VT) Tidal Volume in Litres (L) at body temperature and pressure saturated (BTPS) During exercise testing
Secondary Respiratory Quotient (RQ) Respiratory Quotient (CO2 produced / O2 consumed; no unit as it is a ratio value) During exercise testing
Secondary End-tidal carbon dioxide tension (PETCO2) End-tidal carbon dioxide tension (PETCO2) in millimetres of mercury (mmHg) During exercise testing
Secondary End-tidal oxygen tension (PETO2) End-tidal oxygen tension (PETO2) in millimetres of mercury (mmHg) During exercise testing
Secondary Oxygen Saturation (SpO2) Oxygen Saturation (SpO2) (%, percentage) During exercise testing
Secondary Respiratory Reserve Respiratory Reserve in Litres During exercise testing
Secondary Expiration Time Expiration Time in seconds During exercise testing
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