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CompletedNCT01328899Updated Jul 21, 2021

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

A Phase 1/2 interventional study of Lung Volume Reduction Coil (LVRC) (PneumRx's) in Emphysema, sponsored by Boston Scientific Corporation. Completed at 11 sites in 3 countries. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2021-07-21.

Sponsored by Boston Scientific Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
35 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Emphysema

Keywords

  • Emphysema
  • COPD
  • RePneu
03

In context

Pulmonary Emphysema

187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.

This study's enrollment of 60 is above the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.

Browse Pulmonary Emphysema studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Lung Volume Reduction Coil (LVRC)

    Lung Volume Reduction Coil (LVRC)

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

Interventions

  • DeviceLung Volume Reduction Coil (LVRC) (PneumRx's)

    Lung Volume Reduction Coil

    Also known as: Lung Volume Reduction Device (LVRD)

06

What researchers measure

Primary outcomes

  1. St. George's Respiratory Questionnaire

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

    Time frame: 6 months

07

Study locations

11 sites
  • 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
  • University Medical Center Groningen
    Groningen, Netherlands
08

References and documents

Publications

  • 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. PubMed 25418910 ↗
  • 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. PubMed 24891327 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01328899
Lead sponsor
Boston Scientific Corporation
Collaborators
PneumRx, Inc.
Responsible party
Sponsor
First posted
Apr 5, 2011
Start date
Dec 2009
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Jul 21, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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