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Trial Title:
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
NCT ID:
NCT05582018
Condition:
Hepatocellular Carcinoma
Metastatic Liver Cancer
Conditions: Official terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
BioTraceIO 360
Description:
Use of the device for planning, monitoring and assessment of liver tissue ablations
Arm group label:
BioTrace
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Scheduled and indicated for standard-of-care liver tumor ablation for either
hepatocellular carcinoma (HCC) or metastatic liver tumor(s) microwave (MW) energy.
- Patient must have at least one prior CT or CECT scan (up to 6 months before
enrollment).
- Tumor must be visualized on at least one diagnostic imaging modality (MRI or
contrast-enhanced CT).
- Single tumor, or multiple tumors only if the distance between the ablated tumor and
all other tumors allows for distinct separation between the necrotic zones.
- Distance between the tumor and the edge of any previous necrotic zones allows for
distinct separation between the necrotic zones.
- At least 21 years of age.
- Able and willing to give informed consent.
Additional inclusion criteria for subgroup:
- Single ablation, using a single ablation needle, per tumor.
Exclusion Criteria:
- Planned ablation includes adjunctive means other than MW energy (e.g., ethanol,
hepatic artery embolization, etc.).
- Planned ablation includes the use of more than two ablation needles, per tumor
- Ablation area cannot be visualized and monitored continuously using ultrasound
throughout the entire ablation procedure.
- Pregnant or breastfeeding.
- Patient judged unsuitable for study participation by the physician for any other
reason.
- Currently participating in another clinical trial of an unapproved investigational
device or drug that has not concluded the follow-up period.
- Unable or unwilling to give informed consent.
Additional exclusion criteria for subgroup:
- Liver tumor that cannot be ablated with a single ablation needle, according to the
investigator's clinical opinion.
- Planned ablation includes repositioning and/or overlapping ablations using a single
ablation needle.
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 2023
Completion date:
December 2023
Lead sponsor:
Agency:
Techsomed Medical Technologies LTD
Agency class:
Industry
Source:
Techsomed Medical Technologies LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05582018
