Status:
UNKNOWN
China Alair System Registry Study-CARE Study
Lead Sponsor:
BSC International Medical Trading (Shanghai) Co., Ltd.
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard...
Detailed Description
Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma ...
Eligibility Criteria
Inclusion
- Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.
- Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements.
- Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU).
Exclusion
- Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
- Patient has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT02206269
Start Date
April 1 2015
End Date
June 1 2019
Last Update
February 23 2018
Active Locations (1)
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1
BSC International Medical Trading (Shanghai) Co., Ltd.
Shanghai, Shanghai Municipality, China, 200023