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

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.

Study Overview

• Status: Withdrawn
• Conditions: COPD
• Intervention / Treatment: Device: Targeted Lung Denervation (TLD)

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of advanced COPD [20% ≤ FEV1 ≤ 45% and FEV1/FVC < 70% (post-bronchodilator)] who are no longer smoking (quit at least 2 months prior to registry consent) and are able to undergo general anesthesia. All subjects will undergo a CT scan to determine whether bronchial anatomy is appropriate for TLD procedure.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Targeted Lung Denervation (TLD); Targeted Lung Denervation (TLD) procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life (QOL)	Changes in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) over time will be assessed. Comparisons will be made to baseline score.	6 months; 12 months; 24 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pulmonary Function	Basic spirometry tests including FEV1, FVC, forced impulse oscillometry, nitrogen wash-out measures will be performed per standard of care over time. Comparisons will be made to baseline measures.	6 months, 12 months, 24 months post-procedure
Change in 6-Minute Walk Test	Change in 6MWT over time	6 months, 1 year, 2 years
Respiratory-related Adverse Events	Respiratory-related adverse events will be collected throughout the registry. Rates of respiratory-related adverse events will be reported and compared to historical data.	24 months
Freedom from Device-related Adverse Events	Device-related adverse events will be collected through 6 months post-procedure. The number of subjects free from a device-related adverse event will be reported.	Peri-procedure (within 7 days); 1 month and 6 months

Collaborators and Investigators

• Sponsor: Nuvaira, Inc.

Publications and helpful links

Helpful Links

• Nuvaira Website with description of TLD procedure

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Targeted Lung Denervation; TLD
• Other Study ID Numbers: D0476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No