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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01328899
Other study ID # CLN0011
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2009
Est. completion date January 2013

Study information

Verified date July 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria: - Greater than or equal to 35 years of age - bilateral heterogenous 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 significant respirator 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 clinical significant bronchiectasis - Patient has had previous LVR surgery, lung transplant or lobectomy - Patient has been involved in other pulmonary drug studies within 30 days prior to this study

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Lung Volume Reduction Coil (LVRC) (PneumRx's)
Lung Volume Reduction Coil

Locations

Country Name City State
France CHU de Nice - Hospital Pasteur Nice
France Gaetan Deslee Reims
France CHRU de Strasbourg-NHC Strasbourg
Germany Campus Charite Mitte Berlin
Germany Klinikum Donaustauf Donaustauf
Germany Asklepios Gauting
Germany Thoraxklinik Heidelberg
Germany Lungenklinik Hemer
Germany Krankenhaus von Roten Kreuz Stuttgart
Germany UKT University Hospital Teubingen
Netherlands University Medical Center Groningen Groningen

Sponsors (2)

Lead Sponsor Collaborator
Boston Scientific Corporation PneumRx, Inc.

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary St. George's Respiratory Questionnaire Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline 6 months
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