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

NCT ID: NCT03213080

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2021-09-30

Brief Summary

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.

Detailed 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.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TLD Procedure

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.

Targeted Lung Denervation (TLD)

Intervention Type: DEVICE

Targeted Lung Denervation (TLD) procedure.

Interventions

Targeted Lung Denervation (TLD)

Targeted Lung Denervation (TLD) procedure.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuvaira, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Related Links

https://www.nuvaira.com/

Nuvaira Website with description of TLD procedure

Other Identifiers

D0476

Identifier Type: -

Identifier Source: org_study_id