Post Market Registry Study of the AeriSeal System | NCT01520064

Studies
Post Market Registry Study of the AeriSeal System

NCT01520064

Sponsor

Aeris Therapeutics

Status

Terminated

Last Update Posted

Nov 14, 2013Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Pulmonary Emphysema

Interventions

Not provided

Countries

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

Feb 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jan 25, 2012

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 27, 2012Estimated

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

Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.

Detailed Description

Not provided

Conditions Module

Conditions

Pulmonary Emphysema

Keywords

Emphysema
GOLD Stage III
GOLD Stage IV
AeriSeal System
Homogeneous
Heterogeneous
Upper Lobe Predominant
ULP
Chronic Obstructive Pulmonary Disease
COPD
Lung Volume Reduction Surgery
LVRS
Bronchoscopic Lung Volume Reduction
BLVR

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post Market Registry Study of the AeriSeal System	-Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-martet setting	At least 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced Emphysema
AeriSeal System treatment

Exclusion Criteria:

have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
have had frequent COPD exacerbations within the past year
require mechanical ventilatory support
have a pretreatment DLCO < 20% predicted or > 60% predicted
have a pretreatment FEV1 < 20% predicted AND homogeneous emphysema
have giant bullae
have undergone lung transplantation, lung volume reduction surgery, or lobectomy
are intolerant of corticosteroids or antibiotics
are pregnant or breast-feeding

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

Patients must have been or will be treated with the AeriSeal System

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janine McDermott, MS CCRP	Aeris Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zentralklinik Bad Berka GmbH		Bad Berka		99437	Germany
Klinikum Coburg

Condition Browse Module

MeSH Terms

ID	Term
D011656	Pulmonary Emphysema
D004646	Emphysema
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided