NCT01320566

Brief Summary

The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

10 months

First QC Date

March 15, 2011

Last Update Submit

November 13, 2013

Conditions

Pulmonary EmphysemaChronic Obstructive Pulmonary Disease(COPD)Lung Diseases

Keywords

Polymeric Lung Volume Reduction (PLVR)Bolilogic Lung Volume Reduction (BLVR)AeriSealtreatmentdevicebreathingCOPDemphysemaheterogeneoushomogeneousPathologic ProcessesRespiratory Tract DiseasesLung DiseasesPulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Percent Volume of Lung

    Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.

    48 Weeks following treatment

Secondary Outcomes (6)

  • Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

    24 and 48 weeks following treatment

  • Change in Forced Expiratory Volume in 1 Second (FEV1)

    24 and 48 weeks following treatment

  • Change in Forced Vital Capacity (FVC)

    24 and 48 weeks following treatment

  • Change in distance walked in six minutes

    24 and 48 weeks following treatment

  • Change in Medical Research Council Dyspnea (MRCD) score

    24 and 48 weeks following treatment

  • +1 more secondary outcomes

Interventions

AeriSeal SystemDEVICE

Not applicable. Follow-Up study only.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Soroka Medical Center

Beersheba, 84101, Israel

Location

The Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Related Links

MeSH Terms

Conditions

Pulmonary EmphysemaPulmonary Disease, Chronic ObstructiveLung DiseasesRespiratory AspirationEmphysemaPathologic ProcessesRespiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveChronic DiseaseDisease AttributesPathological Conditions, Signs and SymptomsRespiration Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 22, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

November 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

IL(2)