NCT02104856

Bronchial Thermoplasty Global Registry

Bronchial Thermoplasty (BT) Global Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this Registry is to collect real-world data on patients undergoing bronchial thermoplasty (BT) treatment.

Detailed 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.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Alair System (Bronchial Thermoplasty)

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2014-04-04
• Last updated: 2019-09-13

Locations

19 sites across 8 countries: Australia, Czechia, Germany, Italy, Netherlands, South Africa, Spain, United Kingdom