Clinical trial · Observational
Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
Pivotal Clinical Study to Establish the Safety and Effectiveness of the Use of BioTraceIO Lite for Assessment of Tissue Damage Following Liver Tissue Ablation Procedures
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events. Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioTraceIO Lite | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study Arm
- description
- Subjects will receive your standard liver ablation procedure, including ultrasound images. Data will be collected from the standard liver ablation procedure, including imaging. Subjects will receive a CT scan within 24 hours after the liver ablation procedure. There will then be an analysis of ultrasound images and research CT scan.
- interventionNames
- Device: BioTraceIO Lite
Primary outcomes (2)
- measure
- Safety - Adverse Events
- timeFrame
- 1 year
- description
- Incidence and severity of device-related adverse events (including serious adverse events (SAE)) occurring between the beginning of the liver tissue ablation procedure and the completion of the T=24hrs contrast-enhanced computed tomography (CECT) scan. There is no comparator for this endpoint.
- measure
- Effectiveness - DICE
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either RF or MW energy. 2. At least 21 years of age 3. 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 (minimum of 1cm), based on the physician's discretion. 4. Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician's discretion. 5. Single ablation, using a single ablation needle, per tumor. 6. Able and willing to give informed consent. Exclusion Criteria: 1. Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion. 2. Subject cannot tolerate/undergo contrast-enhanced CT. 3. Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle. 4. Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure. 5. Pregnant or lactating 6. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period. 7. Unable or unwilling to give informed consent.
References
Publications (0)
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