Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

Not Applicable

Completed

• Conditions: Emphysema
• Interventions: Device: Lung Volume Reduction Coil (LVRC); Device: Coils

• Registration Number: NCT01220908
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patient > 35 years of age
• unilateral or bilateral emphysema
• Patient has stopped smoking for a minimum of 8 weeks
• Read, understood and signed the Informed Consent form

Exclusion Criteria

• Patient has a history of recurrent clinically significant respiratory infection
• Patient has an inability to walk >140 meters
• Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
• Patient is pregnant or lactating
• Patient has clinically significant bronchiectasis
• Patient has had previous LVR surgery, lung transplant or lobectomy
• Patient has been involved in other pulmonary drug studies with 30 days prior to this study
• Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
permanent Coil(s) implant, QOL measure	Lung Volume Reduction Coil (LVRC)	Coil implantation as treatment. Treatment is permanent implant.
permanent Coil(s) implant, QOL measure	Coils	Coil implantation as treatment. Treatment is permanent implant.

Primary Outcome Measures

Name	Time	Method
Quality of Life Assessment.	Three + Months Follow-Up Visit	Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ)

Trial Locations

Locations (5)

Klinikum Donaustauf; 🇩🇪 Donaustauf, Germany

Asklepios; 🇩🇪 Gauting, Germany

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Lungenklinik; 🇩🇪 Hemer, Germany

Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg; 🇩🇪 Heidelberg, Germany