NCT02835001

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
2.5 years until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

Same day

First QC Date

July 13, 2016

Last Update Submit

August 19, 2019

Conditions

Emphysema

Outcome Measures

Primary Outcomes (1)

  • Hyperinflation Assessment After Treatment

    Assessed by Lung Volume Reduction Coil

    3 months

Study Arms (1)

Patient with severe emphysema

OTHER

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

Procedure: BronchoscopyDevice: Lung Volume Reduction Coil (HEAT-LVRC)

Interventions

BronchoscopyPROCEDURE

Two sequences of 30 minutes are necessary by patient

Patient with severe emphysema
Lung Volume Reduction Coil (HEAT-LVRC)DEVICE

Bronchoscopy with Heat-LVRC

Patient with severe emphysema

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larrey Hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Emphysema

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Nicolas Guibert, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

January 15, 2019

Primary Completion

January 15, 2019

Study Completion

June 15, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)