A RandomizEd ControlLed Study of PnEumRx Endobronchial Coil System Versus Standard-of-Care Medical MAnagement in the Treatment of Subjects with Severe Emphysema (ELEVATE) A Postmarket Surveillance Study (PMS)
Duration of Study in the UK
1 years, 11 months, 31 days
Emphysema is a chronic disease of the lungs affecting nearly 2% of the population. It is usually caused by smoking. In this disease the lungs lose their normal elasticity and become baggy, trapping too much air in them. This is known as hyperinflation and is one of the main causes of breathlessness in the disease.
Lung volume reduction coils have been shown in previous trials to improve symptoms, quality of life, exercise capacity and lung function in patients with emphsyema. However we still don't know exactly how coils work and who is likely to benefit the most. This study is designed to address these questions by making in depth measurements of lung function, exercise capacity both inside and outside of the hospital and imaging the lungs.
Patients with emphysema, who have had maximal medical treatment will be invited to join the study. They will undergo baseline measurements of lung function, physical activity, exercise capacity and a medical review. It will include radiological (X-ray) scans of their lungs. Should they meet the criteria they will undergo two treatments (one for each lung) separated by three months. This will be performed under general anaesthetic and they will have further measurements of lung elasticity during the procedure. Assessments will be repeated three months after the second treatment as well as monitoring of adverse events during the study.
London - London Bridge Research Ethics Committee
Date of REC Opinion
25 Jul 2018
Further Information Favourable Opinion