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Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
Not Recruiting
Trial ID: NCT04970212
Purpose
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).
Official Title
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
Stanford Investigator(s)
Nishita Kothary, MD
Professor of Radiology (Interventional Radiology)
Eligibility
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.
Intervention(s):
device: BioTraceIO Lite
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Pranav Hegde
650-721-4080