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

Withdrawn

• Conditions: COPD

• Registration Number: NCT03213080
• Lead Sponsor: Nuvaira, Inc.

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.

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Study Start: 2017-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-18
• Primary Completion: 2021-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Change in 6-Minute Walk Test	6 months, 1 year, 2 years	Change in 6MWT over time
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.
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.