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

Trial ID or NCT#

NCT04970212

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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.
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Investigator(s)

Nishita Kothary, MD
Nishita Kothary, MD
Interventional radiologist
Professor of Radiology (Interventional Radiology)

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Contact

Pranav Hegde
650-721-4080

View on ClinicalTrials.gov