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

NCT01328899 | Completed Phase 1

• 1 other identifier: CLN0011
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 11

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.

Conditions

Emphysema

Keywords

Emphysema; COPD; RePneu

Outcome Measures

Primary Outcomes (1)

• St. George's Respiratory Questionnaire

  Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline

  6 months

Study Arms (1)

Lung Volume Reduction Coil (LVRC)

EXPERIMENTAL

Lung Volume Reduction Coil (LVRC)

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

Interventions

Lung Volume Reduction Coil (LVRC) (PneumRx's) DEVICE

Lung Volume Reduction Coil

Also known as: Lung Volume Reduction Device (LVRD)

Lung Volume Reduction Coil (LVRC)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• PneumRx, Inc.: collaborator

Study Sites (11)

CHU de Nice - Hospital Pasteur

Nice, France

Location

Gaetan Deslee

Reims, France

Location

CHRU de Strasbourg-NHC

Strasbourg, France

Location

Campus Charite Mitte

Berlin, Germany

Location

Klinikum Donaustauf

Donaustauf, Germany

Location

Asklepios

Gauting, Germany

Location

Thoraxklinik

Heidelberg, Germany

Location

Lungenklinik

Hemer, Germany

Location

Krankenhaus von Roten Kreuz

Stuttgart, Germany

Location

UKT University Hospital

Teubingen, Germany

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 25418910 DERIVED

• Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.

  PMID: 24891327 DERIVED

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: April 5, 2011
• Study Start: December 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

DE (7); FR (3); NL (1)