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

NCT04970212 | Completed FDA Device

• 1 other identifier: CL000012
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 6

Brief Summary

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).

Conditions

Carcinoma, Hepatocellular; Metastatic Liver Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Sensitivity

  1 year

• Precision

  1 year

• Questionnaire - Effect of BioTraceIO

  1 year

• Difference between T=0 and T=24hrs CECT tissue damage

  1 year

Study Arms (1)

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

Interventions

BioTraceIO Lite DEVICE

The BioTraceIO software will analyze the ultrasound images, and provide the physician with an estimated tissue damage map.

Study Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• At least 21 years of age
• 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.
• 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.
• Single ablation, using a single ablation needle, per tumor.
• Able and willing to give informed consent.

You may not qualify if:

• Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
• Subject cannot tolerate/undergo contrast-enhanced CT.
• 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.
• Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
• Pregnant or lactating
• 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.

Sponsors & Collaborators

• Techsomed Medical Technologies LTD: lead

Study Sites (6)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Stanford Medicine

Stanford, California, 94305, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 21, 2021
• Study Start: September 24, 2021
• Primary Completion: October 8, 2022
• Study Completion: October 8, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)