Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

Not Applicable

Terminated

• Conditions: Emphysema
• Interventions: Procedure: Bronchoscopy; Device: Lung Volume Reduction Coil (HEAT-LVRC)

• Registration Number: NCT02835001
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-15
• Study Start: 2019-01-15
• Primary Completion: 2019-01-15
• Study Completion: 2019-06-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with severe emphysema	Bronchoscopy	Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy
Patient with severe emphysema	Lung Volume Reduction Coil (HEAT-LVRC)	Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy

Primary Outcome Measures

Name	Time	Method
Hyperinflation Assessment After Treatment	3 months	Assessed by Lung Volume Reduction Coil

Trial Locations

Locations (1)

Larrey Hospital; 🇫🇷 Toulouse, France