Hyperinflation Assessment After Treatment by Lung Volume... | NCT02835001

Studies
Hyperinflation Assessment After Treatment by Lung Volume Reduction Coil

NCT02835001

Sponsor

University Hospital, Toulouse

Status

Terminated

Last Update Posted

Aug 21, 2019Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Emphysema

Interventions

Bronchoscopy
Lung Volume Reduction Coil (HEAT-LVRC)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

change of technique

Expanded Access Info

Start Date

Jan 15, 2019Actual

Primary Completion Date

Jan 15, 2019Actual

Completion Date

Jun 15, 2019Actual

First Submitted Date

Jul 13, 2016

First Submission Date that Met QC Criteria

Jul 14, 2016

First Posted Date

Jul 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2019

Last Update Posted Date

Aug 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with severe emphysema	Other	Patients with severe emphysema, stable, symptomatic, not controlled despite of international recommendations treatments will have bronchoscopy	Procedure: Bronchoscopy Device: Lung Volume Reduction Coil (HEAT-LVRC)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bronchoscopy	Procedure	Two sequences of 30 minutes are necessary by patient	Patient with severe emphysema

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas Guibert, MD	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Larrey Hospital		Toulouse		31000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004646	Emphysema

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001999	Bronchoscopy

Ancestor Terms

ID	Term
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided