Clinical trial NCT05582018: Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Metastatic Liver Cancer
Lead sponsor: Techsomed Medical Technologies LTD
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Effectiveness
timeFrame: 1 year
measure: Safety
timeFrame: 1 year
Secondary outcomes:
measure: Planning Module
timeFrame: 1 year
measure: Monitoring Module
timeFrame: 1 year
measure: Assessment Module (1)
timeFrame: 1 year
Other outcomes:
measure: Assessment Module (2)
timeFrame: 1 year
measure: Accuracy
timeFrame: 1 year
measure: Sensitivity
timeFrame: 1 year
measure: Precision
timeFrame: 1 year
Locations:
Study officials:
References: