Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

Emphysema Clinical Trial

— HEAT-LVRC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02835001
• Other study ID #: RC31/15/7857
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

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