NCT05771129

Feasibility Study of the Pulsed Electric Field Ablation System in Treating Chronic Bronchitis

Feasibility and Safety Evaluation of the Pulsed Electric Field Ablation System on Patients With Chronic Bronchitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Jiayuan Sun · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Bronchitis

Interventions

Type	Name	Description
DEVICE	Pulse electric field ablation system developed by Zhouling (Shanghai) Medical Appliance Co., Ltd.	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.

Timeline

• Start date: 2023-03-10
• Primary completion: 2024-03-10
• Completion: 2025-03-10
• First posted: 2023-03-16
• Last updated: 2023-03-16

Locations

1 site across 1 country: China