Status:
COMPLETED
RISA Extension Study - Long Term Safety
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Brief Summary
The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study...
Detailed Description
This will be a multicenter study conducted only at the clinical sites that participated in the PREDECESSOR STUDY (NCT00214539). Enrollment will be limited to only those subjects who were treated with...
Eligibility Criteria
Inclusion
- Subject who participated in the PREDECESSOR STUDY entitled "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair™ System for the Treatment of Severe Asthma" (Protocol # 0903-27).
- Subject was treated with the Alair System ("Alair Group") in the PREDECESSOR STUDY.
- Subject who is able to read, understand, and provide written Informed Consent.
- Subject who is able to comply with the study protocol, including requirements for taking and abstaining from medications, and complete all study required visits.
Exclusion
- Subject participating in another clinical trial involving respiratory intervention that could affect the outcome measures of this study, either within 6 weeks of study enrollment, or during the study period.
- Subject with a newly diagnosed (since exiting from the PREDECESSOR STUDY) psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00401986
Start Date
January 1 2007
End Date
February 1 2011
Last Update
February 1 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90570-080
2
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
3
Hospital Laval, University of Laval
Sainte-Foy, Quebec, Canada, G1V 4G5
4
Gartnavel General Hospital, Univ. Glasgow
Glasgow, United Kingdom