A Phase 2/3 interventional study of Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.) in Emphysema, sponsored by Boston Scientific Corporation. Completed at 1 site in Netherlands. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2021-07-16.
Sponsored by Boston Scientific Corporation · Phase 2/3, Interventional, and Treatment
The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 10 is below the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form
Exclusion Criteria:
Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
Device: Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)
Lung Volume Reduction Coil (LVRC)
Also known as: Lung Volume Reduction Surgery (LVRS), Lobectomy
6 minute walk test (6MWT)
The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up.
Time frame: 6 months
Adverse Events
The safety objective of this study is to identify the adverse effects attributed to device.
Time frame: 6 months
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Boston Scientific Corporation