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

COPD Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema

• NCT number: NCT02012673
• Study type: Interventional
• Source: University Medical Center Groningen
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Completion date: September 2016