Status:
ACTIVE_NOT_RECRUITING
Bronchial Ablation for Treatment of Asthma (BATA) Trial
Lead Sponsor:
SyMap Medical (Suzhou), Ltd.
Collaborating Sponsors:
JieNuo Medical(Beijing)Co.,Ltd
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ma...
Detailed 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). ...
Eligibility Criteria
Inclusion
- Subject is an adult between the ages of 18 to 65 years;
- Diagnosed with asthma who required regular asthma maintenance medication in the past 6 months as follows:
- ICS ≥1000 μg/day beclomethasone or equivalent and LABA ≥1000μg /day salmeterol or equivalent.
- Other medications were allowed, including leukotriene modifiers, and Oral Corticosteroids (OCS) ≤ 10mg/day.
- At least two days of asthma symptoms during 4-weeks of the baseline period.
- Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 45% of predicted.
- Non-smoker (less than 10 pack per year) last for 1 year or greater.
- Baseline AQLQ Score less than or equal to 6.25
- Willingness and ability to comply with the outpatient follow-up.
Exclusion
- Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of less than 45% of predicted.
- 3 or more hospitalizations for exacerbations of asthma in the past 12 months;
- More than 3 lower respiratory tract infections requiring antibiotics in the past 12 months
- More than 4 of oral steroid use for exacerbations of asthma in the past 12 months
- Chronic sinusitis
- Uncontrolled gastroesophageal reflux disease, defined as a significant increase in treatment over the past 6 weeks
- Sensitivity to medications required to perform bronchoscopy (such as lidocaine and benzodiazepines)
- Use of an implantable electrical stimulation device, such as a pacemaker, a cardiac defibrillator or a deep nerve or deep brain stimulator;
- Severe emphysema caused by chronic obstructive pulmonary disease (COPD).
- Use of systemic immunosuppressants, beta adrenergic blockers, or anticoagulants.
- History of fatal asthma.
- Uncontrolled obstructive sleep apnea
- Intubation or admission to the ICU for asthma exacerbations within 2 years prior to treatment
- Hemorrhagic or malignant tumors or Coagulopathy.
- Lower bronchial stenosis or distal complete atelectasis or other severe bronchial and pulmonary lesions, as Thoracic spiral CT showed
- Poor compliance judged by the investigator, or other medical conditions that are not suitable for the study
- Related contraindications for bronchoscopy
- Pregnant, lactating women, or patients with a birth plan in the next year
- Previously undergone bronchial thermoplasty
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03765307
Start Date
June 18 2019
End Date
December 31 2028
Last Update
August 2 2023
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese Pla General Hospital
Beijing, Beijing Municipality, China
2
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
3
University of Chinese Academy of Sciences Shenzhen Hospital
Shenzhen, Guangdong, China
4
Hebei Chest Hospital
Shijiazhuang, Hebei, China