Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
158 participants
OBSERVATIONAL
2014-01-31
2019-06-26
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
OTHER
Study Groups
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Alair System (Bronchial Thermoplasty)
Asthma patients undergoing Bronchial Thermoplasty treatment with commercially available Alair device as per Directions For Use.
Alair System (Bronchial Thermoplasty)
Interventions
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Alair System (Bronchial Thermoplasty)
Eligibility Criteria
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Inclusion Criteria
2. 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Niven, MD
Role: PRINCIPAL_INVESTIGATOR
Wythenshawe Hospital - University of Manchester
Alfons Torrego, MD
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Felix Herth, MD
Role: PRINCIPAL_INVESTIGATOR
Thoraxklinik University of Heidelberg
Locations
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Macquarie University Private Hospital
North Ryde, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Peninsula Health
Frankston, Victoria, Australia
Klinika Tuberkulozy a Respiracnich Onemocneni
Prague, , Czechia
Universitätsklinikum Bonn
Bonn, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, , Germany
Thoraxklinik, University of Heidelberg
Heidelberg, , Germany
University Hospital of Regensburg
Regensburg, , Germany
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Aricispedale Santa Maria Nuova
Reggio Emilia, , Italy
Academic Medical Center
Amsterdam, , Netherlands
University of Cape Town Groote Shuur Hospital
Cape Town, , South Africa
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Germans Trias I Puyol
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
Wythenshawe Hospital University of Manchester
Manchester, , United Kingdom
Countries
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References
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Torrego A, Herth FJ, Munoz-Fernandez AM, Puente L, Facciolongo N, Bicknell S, Novali M, Gasparini S, Bonifazi M, Dheda K, Andreo F, Votruba P, Langton D, Flandes J, Fielding D, Bonta PI, Skowasch D, Schulz C, Darwiche K, McMullen E, Grubb GM, Niven R. Bronchial Thermoplasty Global Registry (BTGR): 2-year results. BMJ Open. 2021 Dec 16;11(12):e053854. doi: 10.1136/bmjopen-2021-053854.
Other Identifiers
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E7086
Identifier Type: -
Identifier Source: org_study_id
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