A Wearable In-phase Chest Wall Vibration Device for Relief of Dyspnoea in COPD: a First-in-human Exploratory Study

Launched by ELEVRE MEDICAL LTD. · May 22, 2024

Keywords

ClinConnect Summary

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 i...

Gender

ALL

Eligibility criteria

• 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

Trial Officials