Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

NCT01220908 | Completed

• 1 other identifier: CLN0006
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 5

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.

Conditions

Emphysema

Keywords

LVRS (Lung Volume Reduction Surgery); LVRC (Lung Volume Reduction Coil); Emphysema; coil; RePneu

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

permanent Coil(s) implant, QOL measure

EXPERIMENTAL

Coil implantation as treatment. Treatment is permanent implant.

Device: Lung Volume Reduction Coil (LVRC); Device: Coils

Interventions

Lung Volume Reduction Coil (LVRC) DEVICE

Implantation of Lung Volume Reduction Coil(s) (LVRC)

Also known as: Lung Volume Reduction Surgery (LVRS), Lobectomy

permanent Coil(s) implant, QOL measure

Coils DEVICE

Lung Volume Reduction Coil(s)

Also known as: Lung Volume Reduction Surgery (LVRS), Lobectomy

permanent Coil(s) implant, QOL measure

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• PneumRx, Inc.: collaborator

Study Sites (5)

Klinikum Donaustauf

Donaustauf, Germany

Location

Asklepios

Gauting, Germany

Location

Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg

Heidelberg, Germany

Location

Lungenklinik

Hemer, Germany

Location

University Medical Center Groningen

Groningen, 3150-3610536, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 25418910 DERIVED

• 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.

  PMID: 22116796 DERIVED

MeSH Terms

Conditions

Emphysema

Interventions

Pneumonectomy; Anterior Temporal Lobectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Neurosurgical Procedures

Study Officials

• Dirk-Jan Slebos, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Prof. Felix JF Herth, MD, PhD

  Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 14, 2010
• Study Start: January 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

NL (1); DE (4)