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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05641922
Other study ID # CL000040
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2023
Est. completion date December 2023

Study information

Verified date November 2022
Source Techsomed Medical Technologies LTD
Contact n/a
Is FDA regulated No
Health authority
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 Single-center prospective single-arm clinical investigation. Sample size - 10 subjects.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
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.

Study Design


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
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
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