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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02835001
Other study ID # RC31/15/7857
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date June 15, 2019

Study information

Verified date August 2019
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC) on Hyperinflation in Severe Emphysema


Description:

Two sequences (around 30 minutes) are necessary by patient. Under general anesthesia, two lobs treatment ( 10 Coil by lob) successively introduced by a bronchoscope.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bronchoscopy
Two sequences of 30 minutes are necessary by patient
Device:
Lung Volume Reduction Coil (HEAT-LVRC)
Bronchoscopy with Heat-LVRC

Locations

Country Name City State
France Larrey Hospital Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hyperinflation Assessment After Treatment Assessed by Lung Volume Reduction Coil 3 months
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