Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391612
Status:
UNKNOWN
Last Update Posted:
2011-01-12
First Post:
2006-10-20
Brief Title:
EASE Trial Exhale Airway Stents for Emphysema
Sponsor:
Broncus Technologies
Organization:
Broncus Technologies
Study Overview
Official Title:
A Randomized Double-blind Study to Evaluate the Safety and Effectiveness of the Exhale Drug-Eluting Stent in Homogeneous Emphysema Subjects With Severe Hyperinflation
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
Brief Summary:
This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass The goal of this research is to see if airway bypass can relieve hyperinflation overfilling of the lungs thereby improving lung function and reducing shortness of breath in patients with severe homogeneous diffuse emphysema EASE stands for Exhale Airway Stents for Emphysema
Detailed Description:
Over 3 million people in the United States and tens of millions more throughout the world live with emphysema a chronic progressive irreversible disease of the lungs The hallmark of emphysema is hyperinflation of the lungs -- air is trapped in the lungs and cannot escape causing the lungs to become larger and larger This makes it difficult to breathe and dyspnea shortness of breath is the result
The airway bypass procedure is performed using a bronchoscope with the patient under anesthesia Very small passageways are created between the damaged lung tissue and the larger breathing passages airways Small stents are inserted to keep the new pathways from closing These pathways could potentially provide a way for the trapped air to escape when the patient exhales If the amount of air trapped in the lungs is reduced then it should be easier for the person to breathe
The EASE study will compare the effects of Exhale Drug-Eluting Stents in patients to a sham-control group of patients who do not receive the stents Two out of three 23 of the participants in the trial will be in the airway bypass group or treatment group Participants in the treatment group will undergo the airway bypass procedure with up to six drug-eluting stents implanted in their lungs creating the passageways for the trapped air to escape A smaller group - one out of three 13 participants - will be the control group The control group will have bronchoscopy but passages will not be made and stents will not be implanted
Participants will need to return to the study center four times during the year for follow-up visits and tests All participants will be told which group they were in when they come back for a follow-up visit one year after the procedure Participants in the control group will be finished with the trial after one year Participants in the treatment group will have a follow-up visit once a year for the next four years to monitor the longer term effects of the airway bypass procedure This is why the end date of the trial is listed as 2012
The airway bypass procedure is performed using a bronchoscope with the patient under anesthesia Very small passageways are created between the damaged lung tissue and the larger breathing passages airways Small stents are inserted to keep the new pathways from closing These pathways could potentially provide a way for the trapped air to escape when the patient exhales If the amount of air trapped in the lungs is reduced then it should be easier for the person to breathe
The EASE study will compare the effects of Exhale Drug-Eluting Stents in patients to a sham-control group of patients who do not receive the stents Two out of three 23 of the participants in the trial will be in the airway bypass group or treatment group Participants in the treatment group will undergo the airway bypass procedure with up to six drug-eluting stents implanted in their lungs creating the passageways for the trapped air to escape A smaller group - one out of three 13 participants - will be the control group The control group will have bronchoscopy but passages will not be made and stents will not be implanted
Participants will need to return to the study center four times during the year for follow-up visits and tests All participants will be told which group they were in when they come back for a follow-up visit one year after the procedure Participants in the control group will be finished with the trial after one year Participants in the treatment group will have a follow-up visit once a year for the next four years to monitor the longer term effects of the airway bypass procedure This is why the end date of the trial is listed as 2012
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None