Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503744
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Transthoracic vs Transbronchial Ablation for Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transthoracic Versus Transbronchial Ablation for Peripheral Lung Cancer Staging IA a Prospective Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer
Detailed Description:
Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture In recent years with the development of navigational bronchoscopy exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety as well as its long-term efficacy This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study randomized in a 11 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups The primary study endpoint is the rate of complete ablation at 6 months post-procedure Secondary study endpoints were success rate of technique implementation complete ablation rate at 12 months post-procedure local control rate at 1 2 and 3 years post-procedure progression-free survival overall survival and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None