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Trial record 39 of 102 for:    Emphysema | Recruiting, Not yet recruiting, Available Studies | "Lung Diseases"

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

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ClinicalTrials.gov Identifier: NCT02835001
Recruitment Status : Not yet recruiting
First Posted : July 15, 2016
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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

Condition or disease Intervention/treatment Phase
Emphysema Procedure: Bronchoscopy Device: Lung Volume Reduction Coil (HEAT-LVRC) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Reduction Lung Volume Reduction by Coil on Hyperinflation in Severe Emphysema
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil [ Time Frame: 3 months ]


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835001


Contacts
Contact: Nicolas Dr Guibert, MD 33 6 30 51 15 52 guibert.n@chu-toulouse.fr

Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Nicolas Guibert, MD University Hospital, Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02835001     History of Changes
Other Study ID Numbers: RC31/15/7857
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases