Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220908
• Other study ID #: CLN0006
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: March 2012

Study information

• Verified date: May 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Lung Volume Reduction Coil (LVRC)
Implantation of Lung Volume Reduction Coil(s) (LVRC)
• Coils
Lung Volume Reduction Coil(s)

Locations

Country	Name	City	State
Germany	Klinikum Donaustauf	Donaustauf
Germany	Asklepios	Gauting
Germany	Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg	Heidelberg
Germany	Lungenklinik	Hemer
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	PneumRx, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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