To preliminarily evaluate the safety and feasibility of the pulsed electric field ablation system independently developed by Zhouling (Shanghai) Medical Appliance Co., Ltd. in the treatment of chronic bronchitis.
Pulsed electric field ablation instrument is a therapeutic instrument based on the irreversible electroporation (IRE) mechanism. The high frequency short duration energy is delivered via a disposable pulse ablation catheter through the bronchoscope and act on the bronchial mucosa, through which goblet cell hyperplasia and airway mucus secretion will be alleviated. The entire treatment consists of two procedure sessions that will be performed one month apart. The first treatment procedure consists of a baseline biopsy of the airway mucosa followed by the treatment of the right lung. The second procedure (one month after right-sided lung treatment) consists of a biopsy of the treated airway, followed by the treatment of the left lung. All procedures will be performed under general anaesthesia. Treatment is considered complete once the two bronchoscopic ablation procedures are successfully completed. A third bronchoscopy will be performed three months following the first treatment where mucosa-biopsy will be taken from the previously treated airway sites to evaluate the histopathological evidence of change in mucus producing cells within the airway after treatment. Subjects will be required to fill questionnaire (SGRQ and CAT ) and complete several examinations (including chest CT scans, respiratory function tests, etc.) during follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Pulsed electric field ablation instrument is a therapeutic instrument based on the irreversible electroporation (IRE) mechanism. The high frequency short duration energy is delivered via a disposable pulse ablation catheter through the bronchoscope and act on the bronchial mucosa, through which goblet cell hyperplasia and airway mucus secretion will be alleviated. The entire treatment consists of two procedure sessions that will be performed one month apart. The first treatment procedure consists of a baseline biopsy of the airway mucosa followed by the treatment of the right lung. The second procedure consists of a biopsy of the treated airway, followed by the left-side treatment. A third bronchoscopy will be performed three months following the first treatment and mucosa-biopsy will be conducted to evaluate the histopathological change in mucus producing cells after treatment. Subjects will also be required to fill questionnaire and complete several examinations during follow-up.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGTo evaluate the rate of adverse events and severe adverse events associated with pulsed electric field ablation systems
1. Index Name: Incidence of surgical or device-related adverse events during and within 1 month of bilateral lung ablation Observation purpose: To evaluate the safety of pulsed electric field ablation. Definition of index: To evaluate the adverse events according to CTCAE v5.0 and evaluate its correlation with the device itself or the operation and calculate the incidence rate of serious adverse events related to the device and the operation treatment. 2. Index Name: The incidence of surgery-or device-related serious adverse events. Observation purpose: To evaluate the safety of pulsed electric field ablation. Definition of index: To evaluate the serious adverse events according to CTCAE v5.0 and evaluate its correlation with the device itself or the operation and calculate the incidence rate of serious adverse events related to the device and the operation treatment.
Time frame: Within 30 days after either the first or second study procedure
Improvements in COPD Version of the St. George Respiratory Questionnaire (SGRQ-C)
To evaluate the changes from baseline in the total score of the COPD Version of the St. George Respiratory Questionnaire (SGRQ-C) at 6 and 12 months after bilateral surgery.
Time frame: 6 and 12 months after bilateral treatment
Improvements in COPD Assessment Test (CAT) score
To evaluate changes from baseline in the COPD Assessment Test (CAT) score at 6 and 12 months after bilateral surgery.
Time frame: 6 and 12 months after bilateral treatment
Clinical Efficacy - Pulmonary Function
To evaluate changes from baseline in forced expiratory volume in the first second (FEV1) in pulmonary function tests (PFT) at 6 and 12 months after bilateral surgery.
Time frame: 6 and 12 months after bilateral treatment
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Pathological examination-goblet cell proliferation score
Baseline, 1 month and 3 months after surgery, the mucosa of the right airway should be biopsied, and obtained tissue should be stained with HE and PAS, in which the proliferation of goblet cells should be compared and scored (semi-quantitative , goblet cells: ciliated cells: 0 point, normal, 1: 10; 1 point, mild hyperplasia, 1: 3-10; 2 points, moderate hyperplasia, 1: 1; 3 points, severe hyperplasia, \> 1: 1)
Time frame: 3 months after treatment on the right side
Acute exacerbation
To evaluate the times of moderate and severe acute exacerbation and the length of hospitalization within 12 months after bilateral operation. Acute exacerbation is defined as the simultaneous occurrence of two or more exacerbations or new episodes of respiratory symptoms, such as short of breath, cough, expectoration, dyspnea or chest tightness, and at least one respiratory symptom lasts for three days or more, resulting in the need for short-acting bronchodilators, or the use of antibiotics and/or oral glucocorticoids (moderate acute exacerbation), or the need for hospitalization or emergency treatment (severe acute exacerbation)
Time frame: 12 months after bilateral treatment
Distal Airway Volume
To evaluate changes from baseline in distal Airway Volume (based on expiratory phase HRCT imaging analysis) at 6 and 12 months after bilateral surgery.
Time frame: 6 and 12 months after bilateral treatment
Incidence of device defects
It refers to the unreasonable risks that may endanger human health and life safety in the normal use of medical devices during the clinical trials, such as labeling errors, quality problems, failures, etc.
Time frame: After bilateral treatment, assessed up to 2 months