Evaluation of the Safety and Efficacy of TLD in Patients With COPD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 520
Summary
- Conditions
- COPD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects will be randomized with equal allocation (1:1) into two arms: TLD therapy plus optimal medical care (Active Treatment) and optimal medical care (Sham Control). Randomization of subjects will be stratified based on investigational site, participation in a pulmonary rehabilitation maintenance program and baseline use of an inhaled corticosteroid at the time of enrollment.Masking: Double (Participant, Outcomes Assessor)Masking Description: Subject and assessor double-blinding will be maintained through 1 year post-procedure.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 40 years and 78 years
- Gender
- Both males and females
Description
The primary objective of this study is to demonstrate the superiority of treatment with the Nuvaira Lung Denervation System (Active Treatment arm) compared to a sham procedure (Sham Control arm) to decrease moderate or severe exacerbations in subjects with COPD on optimal medical care. The secondary...
The primary objective of this study is to demonstrate the superiority of treatment with the Nuvaira Lung Denervation System (Active Treatment arm) compared to a sham procedure (Sham Control arm) to decrease moderate or severe exacerbations in subjects with COPD on optimal medical care. The secondary objective is to compare long-term safety, and other efficacy assessments between the Active Treatment arm and the Sham Control arm.
Tracking Information
- NCT #
- NCT03639051
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Frank Sciurba, MD University of Pittsburgh Medical Center Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Center Groningen
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