Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil (HEAT-LVRC)

Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema

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

Study Overview

• Status: Terminated
• Conditions: Emphysema
• Intervention / Treatment: Procedure: Bronchoscopy; Device: Lung Volume Reduction Coil (HEAT-LVRC)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31000
    • Larrey Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient with severe emphysema; Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy	Procedure: Bronchoscopy; Two sequences of 30 minutes are necessary by patient; Device: Lung Volume Reduction Coil (HEAT-LVRC); Bronchoscopy with Heat-LVRC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperinflation Assessment After Treatment	Assessed by Lung Volume Reduction Coil	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Nicolas GUIBERT, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): June 15, 2019

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: RC31/15/7857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No