Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT05582018
Status:
TERMINATED
Last Update Posted:
2025-09-15
First Post:
2022-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
Sponsor:
Techsomed Medical Technologies LTD
Organization:
Study Overview
Official Title:
Pilot Study to Assess the Safety and Effectiveness of the Use of BioTraceIO 360 for PSM and Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANORAMA
Brief Summary:
Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures
Multi-center (up to 5 investigational sites) prospective single-arm clinical investigation.
Sample size - 30 subjects.
Multi-center (up to 5 investigational sites) prospective single-arm clinical investigation.
Sample size - 30 subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: