Loading clinical trials...

TERMINATEDNA

Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures

Pilot Study to Assess the Safety and Effectiveness of the Use of BioTraceIO 360 for PSM and Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures

NCT05582018•Techsomed Medical Technologies LTD

View on ClinicalTrials.gov

Summary

Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures Multi-center (up to 5 investigational sites) prospective single-arm clinical investigation. Sample size - 30 subjects.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Scheduled and indicated for standard-of-care liver tumor ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) microwave (MW) energy.
•Patient must have at least one prior CT or CECT scan (up to 6 months before enrollment).
•Tumor must be visualized on at least one diagnostic imaging modality (MRI or contrast-enhanced CT).
•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.
•Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones.
•At least 21 years of age.
•Able and willing to give informed consent.
•Single ablation, using a single ablation needle, per tumor.

Exclusion Criteria

•Planned ablation includes adjunctive means other than MW energy (e.g., ethanol, hepatic artery embolization, etc.).
•Planned ablation includes the use of more than two ablation needles, per tumor
•Ablation area cannot be visualized and monitored continuously using ultrasound throughout the entire ablation procedure.
•Pregnant or breastfeeding.
•Patient judged unsuitable for study participation by the physician for any other reason.
•Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
•Unable or unwilling to give informed consent.
•Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
•Planned ablation includes repositioning and/or overlapping ablations using a single ablation needle.

Locations (1)

Einstein Medical Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 5, 2023

Primary Completion Date

April 15, 2024

Completion Date

May 15, 2024

Last Updated

September 15, 2025

Enrollment

ACTUAL participants

Conditions

Hepatocellular CarcinomaMetastatic Liver Cancer

Interventions

BioTraceIO 360

DEVICE

Early Detection of Liver Cancer by QUS

NCT06345508

Hepatocellular CarcinomaLiver Cancer

View study

RECRUITINGPHASE1/PHASE2

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

NCT06811116

Advanced Hepatocellular CarcinomaMetastatic Hepatocellular Carcinoma+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures

Inclusion Criteria

Exclusion Criteria

Early Detection of Liver Cancer by QUS

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)