Trials / Terminated
TerminatedNCT05582018
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Techsomed Medical Technologies LTD · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BioTraceIO 360 | Use of the device for planning, monitoring and assessment of liver tissue ablations |
Timeline
- Start date
- 2023-09-05
- Primary completion
- 2024-04-15
- Completion
- 2024-05-15
- First posted
- 2022-10-17
- Last updated
- 2025-09-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05582018. Inclusion in this directory is not an endorsement.