Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-01 @ 9:35 PM
Study NCT ID:
NCT07132203
Status:
COMPLETED
Last Update Posted:
2025-08-20
First Post:
2025-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases Trial
Sponsor:
Beijing Tiantan Hospital
Organization:
Study Overview
Official Title:
A Multicenter Trial for the Safety and Efficacy of a Magnetic Resonance-Guided Laser Interstitial Thermal Therapy for Brain Metastases
Status:
COMPLETED
Status Verified Date:
2025-08
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:
In accordance with the requirements of the "Good Clinical Practice for Medical Devices", this clinical trial is conducted to further evaluate the safety and efficacy of the magnetic resonance-guided laser ablation treatment system and the laser ablation minimally invasive treatment kit produced by Sinovation (Beijing) Medical Technology. This clinical trial adopts a multi-center, single-groupdesign. After all subjects sign the informed consent form and pass the screening, they will receive the implantation and treatment of the trial products. Follow-up visits will be conducted on the 2±1 day after the surgery, and the efficacy rate of ablation as assessed after the surgery was used as the primary outcome.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: