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Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema

NCT01908933 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2013-11-14

No results posted yet for this study

Summary

The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.

Conditions

  • Emphysema
  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DEVICE

AeriSeal Emphysematous Lung Sealant Syst

This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.

Sponsors & Collaborators

  • Aeris Therapeutics

    lead INDUSTRY

Principal Investigators

  • Felix Herth, Prof. Dr med · Thoraxklinik am Uniklinikum Heidelberg

  • Wolfgang Gesierich, Dr med · Asklepios Fachkliniken Muenchen - Gauting

  • Manfred Wagner, Dr med · Klinikum Nuernberg Nord

  • Mordechai Kramer, Prof · Rabin Medical Center

  • Martin Hetzel, Dr med · Krankenhaus vom Roten Kreuz - Stuttgart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01908933 on ClinicalTrials.gov