Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures

Not Recruiting

Trial ID: NCT04970212


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
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)


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

   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

   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.


device: BioTraceIO Lite

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pranav Hegde

New Trial Alerts