A Study to Assess the BioTraceIO System for Identifying Tissue Damage from Microwave Thermal Liver Ablation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-011589
About this study
The purpose of this study is to evaluate the accuracy of the BioTrace IO during RFA/MWA Transcutaneous procedures.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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Inclusion Criteria:
- Subjects scheduled for standard of care ablation of liver tumors.
- Subjects minimum of 18 years of age.
- Single ablation per tumor.
- 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 (minimum of 1cm), based on the physician’s discretion.
- Distance between the tumor and the edge of any previous necrotic zones allows for distinct separation between the necrotic zones (minimum of 1cm), based on the physician’s discretion.
Exclusion Criteria:
- Subjects with liver tumor size larger than 4 cm will be excluded.
- Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
- Subjects unable to provide consent.
- Any reason subject is deemed unsuitable for the study by the Principal Investigator.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 4/28/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Sadeer Alzubaidi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available