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Bronchial Ablation for Treatment of Asthma (BATA) Trial
Sponsor: SyMap Medical (Suzhou), Ltd.
Summary
To evaluate the safety and efficacy of a bronchial radiofrequency ablation system (SyMap Medical (Suzhou) Ltd) in a population of subjects with severe asthma who are still symptomatic despite being managed on high-dose Inhaled Corticosteroids (ICS) and Long-Acting β2-adrenergic Agonists (LABA).
Official title: Safety and Efficacy of the SyMap Bronchial Ablation System for Treatment of Severe Asthma: A Prospective, Multicenter, Randomized Controlled Clinical Trial (Bronchial Ablation for Treatment of Asthma (BATA) Trial)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2019-06-18
Completion Date
2028-12-31
Last Updated
2023-08-02
Healthy Volunteers
No
Conditions
Interventions
SyMap Bronchial Ablation System
The Bronchial Ablation is performed using SyMap Bronchial Ablation System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.
Boston Scientific Alair System
The Bronchial Thermoplasty is performed using Boston Scientific Alair System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.
Locations (15)
Chinese Pla General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
University of Chinese Academy of Sciences Shenzhen Hospital
Shenzhen, Guangdong, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Affiliated Hospital Of Qiqihar Medical University
Qiqihar, Heilongjiang, China
The First Affilated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Northern Theater Command General Hospital
Shenyang, Liaoning, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China