Status:
UNKNOWN
Lung Volume Reduction Coil Treatment in Emphysema.
Lead Sponsor:
CHU de Reims
Collaborating Sponsors:
PneumRx, Inc.
Conditions:
Emphysema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
* BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volu...
Eligibility Criteria
Inclusion
- Bilateral emphysema on Chest CT Scanner
- Post bronchodilator FEV1 \< 50 %
- Total Lung Capacity \> 100 %
- Residual Volume \> 220 %
- Dyspnea score between 2 and 4 based on the mMRC scale
- Stopped cigarette smoking for more than 8 weeks
- Pulmonary rehabilitation within the previous twelve months
- Consent form signed
- Covered by Medical Insurance
Exclusion
- Post bronchodilator FEV1 \< 15%
- Post-bronchodilator change in FEV1 \> 20%
- Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
- COPD exacerbation requiring hospital stay within 3 months
- Pulmonary Hypertension (Pulmonary systolic pressure \>50 mmHg on cardiac echo)
- Patient unable to perform a 6-min walking test in room air
- Giant bulla of more than 1/3 of the lung field on Chest CT
- Strictly homogeneous emphysema on Chest CT
- Clinically significant bronchiectasis
- Past history of lobectomy, lung volume reduction surgery, lung transplantation
- Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
- Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
- Contra-indication to general anesthesia
- Oral anticoagulant treatment (antivitamin K)
- Allergy to nitinol
- Inclusion in an other study assessing respiratory treatments
- Patient protected by the law
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01822795
Start Date
March 1 2013
End Date
December 1 2019
Last Update
April 30 2014
Active Locations (9)
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1
CHU d'Amiens
Amiens, France, 80054
2
CHU de Grenoble
Grenoble, France, 38043
3
AP-HM
Marseille, France, 13015
4
CHU de Montpellier
Montpellier, France, 34295