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ACTIVE NOT RECRUITING
NCT03765307
NA

Bronchial Ablation for Treatment of Asthma (BATA) Trial

Sponsor: SyMap Medical (Suzhou), Ltd.

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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