A Registry Study of the AeriSeal® System or Lung Volume R... | NCT01449175

Studies
A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

NCT01449175

Sponsor

Aeris Therapeutics

Status

Terminated

Last Update Posted

Nov 14, 2013Estimated

Enrollment

54Estimated

Phase

Not provided

Conditions

Chronic Pulmonary Obstructive Disease
Emphysema

Interventions

Not provided

Countries

Austria
France
Germany
Israel

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 19, 2011

First Submission Date that Met QC Criteria

Oct 7, 2011

First Posted Date

Oct 10, 2011Estimated

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

Nov 13, 2013

Last Update Posted Date

Nov 14, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

Detailed Description

Conditions Module

Conditions

Chronic Pulmonary Obstructive Disease
Emphysema

Keywords

AeriSeal
treatment
device
breathing
COPD
emphysema
polymeric lung volume reduction (PLVR)
biologic lung volume reduction (BLVR)
heterogeneous
homogeneous
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in number of Serious Adverse Events (SAE)	Count number of SAEs during weeks: 48, 96, 120, 144 as a function of long term safety	Weeks 48, 96, 120, 144 following treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in Vital Signs	Change from baseline at 48, 96, 120 and 144 weeks of Vital Signs	weeks 48, 96, 120, 144 following treatment
Change in Oxygen (O2) Use	Change in amount of O2 used (at rest, with activity, during sleep) in weeks 48, 96, 120 and 144 from baseline.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmation of completion of Aeris' post market follow-up Continuation Study, 03-C10-001PLV.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients participating in the Registry Study must have been enrolled in either Group 4 (homogeneous emphysema) or Group 5 (heterogeneous emphysema) of Aeris' Investigational Study 03-C08-003PLV and completed 48 week follow-up in the AeriSeal post market follow-up Continuation Study (03-C10-001PLV).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Otto Wagner Spital Wien		Wein		A-1140	Austria
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004646	Emphysema
D053120	Respiratory Aspiration
D012140	Respiratory Tract Diseases
D008171	Lung Diseases

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided