search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma, Metastatic Liver Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BioTraceIO 360
Sponsored by
Techsomed Medical Technologies LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatocellular Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BioTrace

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.
    Safety
    Incidence and severity of device-related adverse

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    October 12, 2022
    Last Updated
    April 16, 2023
    Sponsor
    Techsomed Medical Technologies LTD
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05582018
    Brief Title
    Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Techsomed Medical Technologies LTD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma, Metastatic Liver Cancer

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    BioTrace
    Arm Type
    Experimental
    Arm Description
    Use of the BioTraceIO 360 device for planning, monitoring and assessment of liver tissue ablations
    Intervention Type
    Device
    Intervention Name(s)
    BioTraceIO 360
    Intervention Description
    Use of the device for planning, monitoring and assessment of liver tissue ablations
    Primary Outcome Measure Information:
    Title
    Effectiveness
    Description
    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.
    Time Frame
    1 year
    Title
    Safety
    Description
    Incidence and severity of device-related adverse
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Planning Module
    Description
    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.
    Time Frame
    1 year
    Title
    Monitoring Module
    Description
    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.
    Time Frame
    1 year
    Title
    Assessment Module (1)
    Description
    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.
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    Assessment Module (2)
    Description
    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.
    Time Frame
    1 year
    Title
    Accuracy
    Description
    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).
    Time Frame
    1 year
    Title
    Sensitivity
    Description
    Sensitivity of the BioTraceIO 360 at T=0 compared to imaging at T=24.
    Time Frame
    1 year
    Title
    Precision
    Description
    Precision of the BioTraceIO 360 at T=0 compared to imaging at T=24.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Inbal Amitai
    Phone
    +972-524878080
    Email
    inbal.amitai@techsomed.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yossi Abu
    Phone
    +972-547886251
    Email
    yossi.abu@techsomed.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs