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A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
1.1 Aims:This cohort study aims to investigate the clinical value of Hybrid APC for treatment of early central lung neoplasms. 1.2 methods:A total of 30 patients with early central lung neoplasms will be included in this open, multicenter, prospective study. Primary observation endpoint is recorded at 3 months follow-up, and after 3 months patients could be continued to follow up. The data are expressed in terms of mean and percentage. The categorical variables are analyzed by chi-square test, and the four table data is analyzed using the exact probability method. The continuous variable analysis is used by t test. Statistical analysis is performed with SPSS 20.0 software. P \< 0.05 is considered statistically significant.
This is a prospective, multicenter, and cohort study. Study subjects: patients with early central lung neoplasms meet inclusion/exclusion criteria and could receive interventional therapy. There are 3 study site in this study and a total of 30 patients with early central lung cancer will be included. HybridAPC is integrated with traditional APC and water-jet technique, which has been successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial lesion, and then APC can be more effective in ablation of superficial tumor with a protection for muscular layer. The application of HybridAPC in respiratory intervention could theoretically protect cartilage, adventitia, reduce damage and formation of scare, and increase ablation energy to reach radical treatment.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Start Date
December 26, 2018
Primary Completion Date
February 22, 2022
Completion Date
December 30, 2023
Last Updated
July 10, 2025
15
ACTUAL participants
Hybrid APC
PROCEDURE
Lead Sponsor
Jiayuan Sun
Collaborators
NCT07143110
NCT06885697
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04577599