Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures (PANORAMA2)
NCT ID: NCT05641922
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-07-31
2023-12-31
Brief Summary
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Single-center prospective single-arm clinical investigation.
Sample size - 10 subjects.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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BioTrace
Use of the BioTraceIO 360 device for planning, monitoring and assessment of liver tissue ablations
BioTraceIO 360
Use of the device for planning, monitoring and assessment of liver tissue ablations
Interventions
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BioTraceIO 360
Use of the device for planning, monitoring and assessment of liver tissue ablations
Eligibility Criteria
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Inclusion Criteria
* 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.
\- Single ablation, using a single ablation needle, per tumor.
Exclusion Criteria
* 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.
* 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.
21 Years
ALL
No
Sponsors
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Techsomed Medical Technologies LTD
INDUSTRY
Responsible Party
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Other Identifiers
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CL000040
Identifier Type: -
Identifier Source: org_study_id