The REVOLENSclinical trial Lung volume reduction with coils has been shown to significantly improve breathlessness and exercise capacityas well has quality of life in patients suffering severe emphysema. The Revolens project is supported by the French Ministry of health and is intended to validate the clinical utility and medico-economic efficiency of this innovative technique. Medical doctors throughout France are participating in this project.
Health authorities and ethic committee authorizations are pending
Overview of the study
If you want to participate in this study, you will first have to undergo measurements of your respiratory capacity (pulmonary function tests) in order to check if you are eligible for the study. If you are eligible and if you decide to participate in this study, you will be separated into 2 groups: treatment group (who will get the Coils) and control group (who will continue getting routine care). The distribution between each group is done randomly (like picking a name out of a hat). Even though this may look surprising this is standard practice in medical research to evaluate new treatments in an objective and unbiaised way.
If you are assigned to the treatment group (50% chance) your right or left lung will be treated first. Treatment of the contralateral lung (same on the other side) will take place 1 to 3 months later. During the year following treatment with coils, you will go on with your usual medical treatment and will be followed every 3 months to monitor your general and respiratory condition. During this follow-up, pulmonary function test as well as clinical examination will be performed by the doctors responsible for the study who will also ask you questions regarding your quality of life and your breathlessness.
If you are assigned to the control group, instead of receiving the coils immediately you will maintain your usual treatment for 1 year and during this year you will be followed-up every 3 months as in the treatment group. After one year, the doctors responsible for the study will offer you the possibility to be treated with the coils provided you still qualify and the health authorities consider this treatment as safe and effective. If you choose to be treated with coils the follow-up will continue for at least another year.