Trial Search Results

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

Clinical study planned to demonstrate that the BioTraceIO Lite Tissue Damage Map (TDM), available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.

Multi-center (up to 5 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Techsomed Medical Technologies LTD

Stanford Investigator(s):

Intervention(s):

  • Device: BioTraceIO Lite

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 is at least 8 cm

   4. Distance between the tumor and the edge of any previous necrotic zones is at least 5
   cm.

   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 discretion.

   2. Subject cannot tolerate/undergo contrast-enhanced CT (e.g., due to contrast media
   allergy)

   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.

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Pranav Hegde
650-721-4080
Recruiting