Clinical trial NCT01220908: Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema
Official title: Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Keywords: LVRS (Lung Volume Reduction Surgery)
LVRC (Lung Volume Reduction Coil)
Emphysema
coil
RePneu
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2010-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life Assessment.
timeFrame: Three + Months Follow-Up Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Donaustauf
country: Germany
facility: Klinikum Donaustauf
city: Gauting
country: Germany
facility: Asklepios
city: Heidelberg
country: Germany
facility: Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Dirk-Jan Slebos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg
name: Prof. Felix JF Herth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.