Discover TLD
Research type
Research Study
Full title
Discovery of the impact of Targeted Lung Denervation (TLD) on the severe and very severe COPD Population
IRAS ID
233479
Contact name
Pallav Shah
Contact email
Sponsor organisation
Nuvaira Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Chronic obstructive pulmonary disease (COPD) affects nearly three million people in the UK. It causes debilitating symptoms of breathlessness and exercise intolerance. One of the major causes of these symptoms is the narrowing of the airways within the lungs. This occurs due to inflammation and contraction of the smooth muscle lining the airways. The smooth muscle contraction is controlled by the vagus nerve. Currently we use medications such as tiotropium to help open up the airways by blocking the effect of the vagus nerve. This isn't effective for everyone and means taking inhalers every day. An operation to cut the vagus nerve improves lung function by stopping the nerve from causing contraction of the smooth muscle. However this is not routinely performed as it has significant risks and will affect other organs. The Nuvaira Targeted Lung Denervation (TLD) system is a minimally invasive way to ablate the branches of the vagus nerve that only supply the lung. The intention is that by removing the effect of the vagus nerve that there will be a sustained improvement in lung function and symptoms by helping open up narrowed airways. TLD Therapy has the potential to provide long-term sustained improvements in lung function which are similar to the transient peak effectiveness of inhaled drugs such as tiotropium.
This aim of this study is to evaluate the overall COPD patient experience with the Nuvaira System. It will also allow for continued collection of safety and effectiveness data, looking specifically at a more severe section of COPD patients than those enrolled in previous TLD trials. It is a multicentre, prospective, single-arm study. The primary outcome measure is health-related quality of life. Subjects will be followed-up for 2 years following their treatment.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
18/EE/0024
Date of REC Opinion
22 Jan 2018
REC opinion
Favourable Opinion