Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

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.

Study Overview

• Status: Completed
• Conditions: Emphysema
• Intervention / Treatment: Device: Lung Volume Reduction Coil (LVRC); Device: Coils

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Donaustauf, Germany
    • Klinikum Donaustauf
  • Gauting, Germany
    • ASklepios
  • Heidelberg, Germany
    • Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
  • Hemer, Germany
    • Lungenklinik
• Netherlands
  • Groningen, Netherlands, 3150-3610536
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: permanent Coil(s) implant, QOL measure; Coil implantation as treatment. Treatment is permanent implant.	Device: Lung Volume Reduction Coil (LVRC); Implantation of Lung Volume Reduction Coil(s) (LVRC); Other Names: Lung Volume Reduction Surgery (LVRS); Lobectomy; Device: Coils; Lung Volume Reduction Coil(s); Other Names: Lung Volume Reduction Surgery (LVRS); Lobectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: PneumRx, Inc.
• Investigators: Principal Investigator: Prof. Felix JF Herth, MD, PhD, Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg; Principal Investigator: Dirk-Jan Slebos, MD, PhD, University Medical Center Groningen

Publications and helpful links

General Publications

• Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.
• Slebos DJ, Klooster K, Ernst A, Herth FJF, Kerstjens HAM. Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. Chest. 2012 Sep;142(3):574-582. doi: 10.1378/chest.11-0730.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: September 30, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Emphysema; LVRS (Lung Volume Reduction Surgery); LVRC (Lung Volume Reduction Coil); coil; RePneu
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: CLN0006