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

Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328899
• Other study ID #: CLN0011
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

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