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

NCT03213080 | Withdrawn

• 1 other identifier: D0476
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COPD

Keywords

Targeted Lung Denervation; TLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in Pulmonary Function

  6 months, 12 months, 24 months post-procedure

• Change in 6-Minute Walk Test

  6 months, 1 year, 2 years

• Respiratory-related Adverse Events

  24 months

• Freedom from Device-related Adverse Events

  Peri-procedure (within 7 days); 1 month and 6 months

Study Arms (1)

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)

Interventions

Targeted Lung Denervation (TLD) DEVICE

Targeted Lung Denervation (TLD) procedure.

TLD Procedure

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuvaira, Inc.: lead

Related Links

• Nuvaira Website with description of TLD procedure

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: December 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share