Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572540
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transthoracic Versus Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer A Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer
Detailed Description:
Ablation therapy has been widely used in the treatment of peripheral lung cancer Among various ablation techniques cryoablation has been demonstrated to be therapeutic efficacy with several advantages including high safety clear ablation borders and minimal local pain With the development of navigational bronchoscopy pilot study on transbronchial cryoablation for peripheral lung cancer has proved its efficacy and safety but there is a lack of prospective randomized controlled trials to verify its near-term as well as long-term efficacy and safety This study was designed as a prospective randomized controlled multicenter clinical trial A total of 110 participants will be randomly assigned to either the transbronchial group or the transthoracic group in a 11 ratio The primary endpoint is the complete ablation rate at 12 months post-ablation Secondary endpoints include technical success rate complete ablation rate at 6 months post-ablation local control rate at 1 2 and 3 years post-ablation 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