Clinical trial NCT03213080: Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population
Official title: Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COPD
Keywords: Targeted Lung Denervation
TLD
Lead sponsor: Nuvaira, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Quality of Life (QOL)
timeFrame: 6 months; 12 months; 24 months post-procedure
Secondary outcomes:
measure: Changes in Pulmonary Function
timeFrame: 6 months, 12 months, 24 months post-procedure
measure: Change in 6-Minute Walk Test
timeFrame: 6 months, 1 year, 2 years
measure: Respiratory-related Adverse Events
timeFrame: 24 months
measure: Freedom from Device-related Adverse Events
timeFrame: Peri-procedure (within 7 days); 1 month and 6 months
Other outcomes:
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