Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)

Phase 1

Completed

• Conditions: Emphysema
• Interventions: Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)

• Registration Number: NCT01328899
• Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung Volume Reduction Coil (LVRC)	Lung Volume Reduction Coil (LVRC) (PneumRx's)	Lung Volume Reduction Coil (LVRC)

Primary Outcome Measures

Name	Time	Method
St. George's Respiratory Questionnaire	6 months	Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline

Trial Locations

Locations (11)

CHU de Nice - Hospital Pasteur; 🇫🇷 Nice, France

Gaetan Deslee; 🇫🇷 Reims, France

CHRU de Strasbourg-NHC; 🇫🇷 Strasbourg, France

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, Germany

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