Bronchial Ablation for Treatment of Asthma (BATA) Trial (BATA)

  • STATUS
    Recruiting
  • participants needed
    160
  • sponsor
    SyMap Medical (Suzhou), Ltd.
Updated on 1 February 2023
corticosteroids
bronchodilator
forced expiratory volume
beclomethasone
salmeterol

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).

Description

This will be a prospective, multicenter, randomized, clinical study comparing the SyMap bronchial radiofrequency ablation system to the Boston Scientific Bronchial Thermoplasty System (Alair System). The study population consisted of subjects with severe asthma who are still symptomatic despite being managed on high dose ICS and LABA. Patients with severe asthma who still have symptoms, despite the standard drug maintenance recommended by the guidelines, after signing the informed consent, who meet the inclusion exclusion criteria enter the baseline period and continued to use uniform ICS and LABA, which will last at least 4 weeks. Patients with at least two days asthma symptoms during the baseline period, and meet the eligibility criteria are assigned to the experimental or control group at a 1:1 ratio based on a central randomized system. A total of 160 subjects will be enrolled, 80 in the experimental group and 80 in the control group. The experimental group is treated with SyMap radiofrequency ablation system, and the control group is treated with the same procedure using Boston Scientific Bronchial Thermoplasty Aliar System. For subjects in the experimental group and the control group, follow-up by telephone call will be performed at 1, 2, 7 days after each procedure and at 1, 2, 4, 5, 7, 8, 9, 10, and 11 months after the third procedure, and outpatient follow-up will be performed at 6 weeks, 3, 6 and 12 months after the third procedure. ICS and LABA are administered within one year after the third procedure. The difference in the rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year), at 12 months after bronchial radiofrequency ablation, is the primary endpoint of the study, and the success rate of procedure, postoperative adverse events, and serious adverse events are safety endpoints.

Details
Condition Asthma
Treatment SyMap Bronchial Ablation System, Boston Scientific Alair System
Clinical Study IdentifierNCT03765307
SponsorSyMap Medical (Suzhou), Ltd.
Last Modified on1 February 2023

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