Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population (DISCOVER TLD)

Nuvaira

Status: Withdrawn

Conditions: COPD

Treatments: Device: Targeted Lung Denervation (TLD)

Study type: Observational

Funder types: Industry

Identifiers

NCT03213080

D0476

Details and patient eligibility

About

The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe.

Full description

The purpose of this study is to evaluate the overall COPD patient experience with the Nuvaira™ Lung Denervation System and allow for the continued collection of safety and effectiveness data on the CE-marked product. The study is a multicenter, prospective, single-arm study designed to include patients, on average, who fall within a more severe stage of COPD, defined as 20-45% FEV1 percent predicted. Subjects will remain on respiratory medications per their standard of care and will be followed and tested per standard of care throughout the study.

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD with 20% ≤ FEV1 ≤ 45% and FEV1/FVC < 70% (post-bronchodilator)
• History of long-term smoking, but non-smoking for a minimum of 2 months prior to study consent
• Patient is a candidate for bronchoscopy
• Patient agrees to all follow-up and provides written informed consent.

Exclusion criteria

• Presence of lung or chest implants (eg. metal stent, valves, coils)
• Pregnancy
• Pre-existing pulmonary hypertension
• Patient has a pacemaker, internal defibrillator, or other implantable electronic device
• Inappropriate bronchial anatomy for procedure (per CT scan)
• Previous abdominal surgical procedures on stomach, esophagus or pancreas
• Previous treatment with TLD Therapy (in same areas)
• Known allergy to bronchoscopy or general anesthesia medications
• Inability to tolerate single lung ventilation for at least 2 min, 30 sec
• Patient has a GCSI score of ≥ 18 at time of screening visit

Trial design

0 participants in 1 patient group

TLD Procedure

Description:

All subjects who are enrolled and meet the eligibility criteria will undergo Targeted Lung Denervation (TLD). TLD is a bronchoscopically-guided, minimally-invasive procedure using the Nuvaira™ Lung Devervation System. The Nuvaira System is intended for the long-term maintenance treatment of airway obstruction associated with COPD. TLD uses radiofrequency (RF) energy to ablate the airway nerve trunks of the vagus nerves that travel parallel to and outside of the main bronchi and into the lungs. Ablation of the nerves opens the airways and makes breathing easier.

Treatment:

Device: Targeted Lung Denervation (TLD)