NCT02012673

A Safety and Feasibility Study of Re-treating Patients With Severe Emphysema With the RePneu LVRC System.

The Safety and Feasibility of Re-treating Patients With Severe Emphysema With the RePneu LVRC System: a Pilot Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Rationale: The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline. Objective: To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.

Detailed description

Rationale: The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline. Objective: To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system. Study design: This study is a non randomized uncontrolled intervention. Study population: Patients with severe emphysema who have previously been treated with the lung volume reduction coil system and significantly improved in lung function, exercise capacity or quality of life, 6 months after the treatment. Intervention: Patients will receive a lung volume reduction coil treatment by bronchoscopy. Main study parameter: The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects. Secondary study parameters: Lung function * Change in RV, 6 months following treatment * Change in RV/TLC ratio, 6 months following treatment * Changes in FEV1 and FVC, 2 and 6 months following treatment Quality of life * Change in the SGRQ score, 2 and 6 months following treatment * Change in the CCQ score, 2 and 6 months following treatment Functional measures * Change in the mMRC score, 2 and 6 months following treatment * Change in the 6MWD, 2 and 6 months following treatment

Conditions

• COPD
• Emphysema

Interventions

Type	Name	Description
DEVICE	Bronchoscopic lung volume reduction	Bronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system. The RePneu LVRC is an implantable device, delivered through a fiber-optic bronchoscope, designed specifically to treat patients suffering from emphysema. The Coil is intended to compress the most damaged parenchyma and tension the surrounding tissue, which increases elastic recoil, reduces hyperinflation and redirects air to healthier portions of the lung for more effective ventilation.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-12-16
• Last updated: 2017-06-27

Locations

1 site across 1 country: Netherlands