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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma; Metastatic Liver Cancer
• Intervention / Treatment: Device: BioTraceIO 360

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inbal Amitai; Phone Number: +972-524878080; Email: inbal.amitai@techsomed.com
• Study Contact Backup: Name: Yossi Abu; Phone Number: +972-547886251; Email: yossi.abu@techsomed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Additional inclusion criteria for subgroup:

• 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.

Additional exclusion criteria for subgroup:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioTrace; Use of the BioTraceIO 360 device for planning, monitoring and assessment of liver tissue ablations	Device: BioTraceIO 360; Use of the device for planning, monitoring and assessment of liver tissue ablations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Incidence and severity of device-related adverse	1 year
Effectiveness	The percentage of patients for whom (1) probe(s) position suggestion provided by the BioTraceIO 360 device is in agreement with the planned probe(s) position, as determined by the physician without the use of the device, or (2) clinically feasible probe(s) positioning suggestion was provided by the BioTraceIO 360 device, in addition to the planned probe(s) position by the physician without the use of the device.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Planning Module	The proportion of subjects in whom the physician has made changes and/or reported increased confidence to the planned ablation procedure after using the BioTraceIO 360 Planning Module compared to without using it.	1 year
Monitoring Module	A non-validated qualitative assessment for the physician regarding confidence during the procedure without and with the use of BioTraceIO 360 Monitoring Module if they could have made clinical decisions based on the use of the device.	1 year
Assessment Module (1)	A non-validated qualitative assessment on whether there were subjects, in whom the physician indicated that they would have changed the procedure and/or follow-up decision if they could have made clinical decisions based on the visualization of the tumor compared to the necrosis, using the BioTraceIO 360 Assessment Module at the end of the procedure.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment Module (2)	A non-validated qualitative assessment on whether there were subjects, for whom the BioTraceIO 360 Assessment Module indicated an incomplete ablation of the target tissue, compared to follow up 1-month post-procedure imaging.	1 year
Accuracy	A paired comparison between the DICE similarity coefficient, assessed for BioTraceIO 360 as measured during the ablation procedure (T=0) and the tissue damage area based on 24-hours post-procedure imaging (T=24), to the DICE similarity coefficient, assessed between the tissue damage area based on immediately post-procedure imaging (T=0) and the tissue damage area based on 24-hours post-procedure imaging (T=24).	1 year
Sensitivity	Sensitivity of the BioTraceIO 360 at T=0 compared to imaging at T=24.	1 year
Precision	Precision of the BioTraceIO 360 at T=0 compared to imaging at T=24.	1 year

Collaborators and Investigators

• Sponsor: Techsomed Medical Technologies LTD

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: October 1, 2022

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; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: CL000030

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: No