Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05771129
Status:
RECRUITING
Last Update Posted:
2023-03-16
First Post:
2023-02-22
Brief Title:
Feasibility Study of the Pulsed Electric Field Ablation System in Treating Chronic Bronchitis
Sponsor:
Jiayuan Sun
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
Feasibility and Safety Evaluation of the Pulsed Electric Field Ablation System on Patients With Chronic Bronchitis
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None