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Clinical Trials/NL-OMON35800
NL-OMON35800
Completed
Phase 2

Evaluation of the PneumRx, Inc. Lung Volume Reduction Device for the Treatment of Subjects with Homogeneous Emphysema - LVR-coil study CLN0012

PneumRx0 sites10 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
PneumRx
Enrollment
10
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
PneumRx

Eligibility Criteria

Inclusion Criteria

  • •Homogeneous emphysema on CT\-thorax
  • •Post\-bronchodilator FEV1 \< 35% predicted
  • •Total Lung Capacity \> 120% predicted
  • •Residual Volume \> 225% predicted
  • •mMRC dyspnea score \>2
  • •Stopped smoking \> 6 months

Exclusion Criteria

  • •History of recurrent respiratory infections
  • •Cardiovasculair pathology
  • •Inability to walk \> 140 meters in 6 minutes
  • •Giant bullae (\> 1/3 lung volume)
  • •Patient is taking \> 20 mg prednisone (or similar steroid) daily
  • •Patient has evidence of other disease that may compromise survival (such as lung cancer, renal failure etc)

Outcomes

Primary Outcomes

Not specified

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