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

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

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).

Study Overview

• Status: Completed
• Conditions: Carcinoma, Hepatocellular; Metastatic Liver Cancer
• Intervention / Treatment: Device: BioTraceIO Lite

Detailed Description

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) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.

BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment.

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).

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Stanford, California, United States, 94305
      • Stanford Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have been scheduled to have a liver ablation as part of their clinical care.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Arm; Subjects will receive your standard liver ablation procedure, including ultrasound images. Data will be collected from the standard liver ablation procedure, including imaging. Subjects will receive a CT scan within 24 hours after the liver ablation procedure. There will then be an analysis of ultrasound images and research CT scan.	Device: BioTraceIO Lite; The BioTraceIO software will analyze the ultrasound images, and provide the physician with an estimated tissue damage map.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Adverse Events	Incidence and severity of device-related adverse events (including serious adverse events (SAE)) occurring between the beginning of the liver tissue ablation procedure and the completion of the T=24hrs contrast-enhanced computed tomography (CECT) scan. There is no comparator for this endpoint.	1 year
Effectiveness - DICE	Paired comparison of the DICE similarity coefficient, assessed between BioTraceIO Lite, as measured at end of ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24), and the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure CECT (T=0) and the tissue damage area based on 24-hours post-procedure CECT (T=24).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.	1 year
Precision	Precision of the BioTraceIO Lite at T=0 compared to CECT at T=24hrs.	1 year
Questionnaire - Effect of BioTraceIO	The proportion of subjects in whom the treating physician indicates that, if the BioTraceIO Lite results had been available for use in patient management, it would have impacted their follow-up plan for patient management, compared to the CECT alone.	1 year
Difference between T=0 and T=24hrs CECT tissue damage	Difference in percentage between tissue damage volume as visualized at T=0 contrast-enhanced computed tomography (CECT) versus tissue damage volume as visualized at T=24hrs CECT.	1 year

Collaborators and Investigators

• Sponsor: Techsomed Medical Technologies LTD

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Actual): October 8, 2022
• Study Completion (Actual): October 8, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 11, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: CL000012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No