Emphysema Clinical Trial
— HEAT-LVRCOfficial title:
Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema
Verified date | August 2019 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema
Status | Terminated |
Enrollment | 20 |
Est. completion date | June 15, 2019 |
Est. primary completion date | January 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years and older |
Eligibility |
Inclusion Criteria: - Severe emphysema (recent CT-scan (< 6 mois) ) - Age > 35 ans - Modified Medical Research Council Scale (mMRC) > 2 - Forced expiratory volume in one second (FEV1) post-bronchodilatator < 45% - Residual volume > 175% - Total Pulmonary capacity > 100% Exclusion Criteria: - Forced expiratory volume in one second (FEV1) variability > 20% after bronchodilatator - Carbon Monoxide Diffusing Capacity (TLCO) < 20% - Recurrent respiratory infection Infections with clinics symptoms - Pulmonary arterial hypertension (PAH) with Pulmonary Arterial Systolic Pressure (PAPS) estimated with echography > 50 mm Hg - Impossibility to walk more that 140 meter (6 min test) - Surgery history of volume reduction or pulmonary transplantation - Broncho-dilatation with clinic symptoms |
Country | Name | City | State |
---|---|---|---|
France | Larrey Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hyperinflation Assessment After Treatment | Assessed by Lung Volume Reduction Coil | 3 months |
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