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

• Sponsor: Nuvaira, Inc. (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT03213080
• Collaborator: (none)
• Enrollment: 0
• Anticipated Duration (Months): 45

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD	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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population
• Anticipated Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Sep 1, 2021

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Change in Quality of Life (QOL) [6 months; 12 months; 24 months post-procedure]

   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.

Secondary Outcome Measures

1. Changes in Pulmonary Function [6 months, 12 months, 24 months post-procedure]

   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.

2. Change in 6-Minute Walk Test [6 months, 1 year, 2 years]

   Change in 6MWT over time

3. Respiratory-related Adverse Events [24 months]

   Respiratory-related adverse events will be collected throughout the registry. Rates of respiratory-related adverse events will be reported and compared to historical data.

4. Freedom from Device-related Adverse Events [Peri-procedure (within 7 days); 1 month and 6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nuvaira, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Nuvaira Website with description of TLD procedure

Publications

None provided.

• Responsible Party: Nuvaira, Inc.
• ClinicalTrials.gov Identifier: NCT03213080
• Other Study ID Numbers: D0476
• First Posted: Jul 11, 2017
• Last Update Posted: Feb 18, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nuvaira, Inc.: Targeted Lung Denervation; TLD

Study Results

No Results Posted as of Feb 18, 2019