Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03537378
Status:
UNKNOWN
Last Update Posted:
2019-09-04
First Post:
2018-05-15
Brief Title:
Hybrid APC Therapy in Early Central Lung Neoplasms
Sponsor:
Jiayuan Sun
Organization:
Shanghai Chest Hospital
Study Overview
Official Title:
A Multi-Center Clinical Study of the Hybrid APC Therapy in Early Central Lung Neoplasms
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
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:
11 AimsThis cohort study aims to investigate the clinical value of Hybrid APC for treatment of early central lung neoplasms
12 methodsA 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 200 software P 005 is considered statistically significant
12 methodsA 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 200 software P 005 is considered statistically significant
Detailed Description:
This is a prospective multicenter and cohort study Study subjects patients with early central lung neoplasms meet inclusionexclusion 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
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
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