Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
NCT05582018 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-09-15
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.
Conditions
- Hepatocellular Carcinoma
- Metastatic Liver Cancer
Interventions
- DEVICE
-
BioTraceIO 360
Use of the device for planning, monitoring and assessment of liver tissue ablations
Sponsors & Collaborators
-
Techsomed Medical Technologies LTD
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-05
- Primary Completion
- 2024-04-15
- Completion
- 2024-05-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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