Bronchial Thermoplasty Global Registry (BTGR)
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About
The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.
Full description
This Registry is a prospective, open-label, single arm, observational registry to collect outcome data as well as clinical and demographic characteristics of patients undergoing BT treatment in the "real world" setting. Patients will be recruited at participating study centers that offer BT as a treatment option to patients with asthma who remain symptomatic despite taking standard of care maintenance medications.
The Registry will be conducted at up to 80 sites globally and will enroll up to 500 patients. The treatment period is from the date of the first BT procedure until 6 weeks after the third (last) procedure (approximately 12 weeks). The post-treatment period starts at the date of the 6-week follow up visit after completion of the third (last) BT procedure for 2-years of follow-up.
The primary endpoint will be the proportion of patients who experience severe asthma exacerbations at 1 and 2 years following BT treatment with the Alair System.
Enrollment
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Volunteers
Inclusion criteria
- Patient is an adult aged 18 years or older and is scheduled to undergo BT treatment according to the Alair System DFU.
- Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the registry requirements.
Exclusion criteria
- Patient has any medical condition that would make them inappropriate for BT treatment, in the Investigator's opinion.
Trial design
158 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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