Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

NCT ID: NCT02835001

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2019-06-15

Brief Summary

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

Detailed Description

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

Conditions

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Emphysema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient with severe emphysema

Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy

Group Type OTHER

Bronchoscopy

Intervention Type PROCEDURE

Two sequences of 30 minutes are necessary by patient

Lung Volume Reduction Coil (HEAT-LVRC)

Intervention Type DEVICE

Bronchoscopy with Heat-LVRC

Interventions

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Bronchoscopy

Two sequences of 30 minutes are necessary by patient

Intervention Type PROCEDURE

Lung Volume Reduction Coil (HEAT-LVRC)

Bronchoscopy with Heat-LVRC

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Guibert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Larrey Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31/15/7857

Identifier Type: -

Identifier Source: org_study_id

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