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

Hepatocellular Carcinoma Clinical Trial

— PANORAMA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05582018
• Other study ID #: CL000030
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Techsomed Medical Technologies LTD
• Contact: Inbal Amitai
• Phone: +972-524878080
• Email: inbal.amitai[@]techsomed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms
• Metastatic Liver Cancer

Intervention

Device:
• BioTraceIO 360
Use of the device for planning, monitoring and assessment of liver tissue ablations

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Techsomed Medical Technologies LTD

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Sensitivity	Sensitivity of the BioTraceIO 360 at T=0 compared to imaging at T=24.	1 year
Other	Precision	Precision of the BioTraceIO 360 at T=0 compared to imaging at T=24.	1 year
Primary	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
Primary	Safety	Incidence and severity of device-related adverse	1 year
Secondary	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
Secondary	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
Secondary	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