A Study to Assess the BioTraceIO System for Identifying Tissue Damage from Microwave Thermal Liver Ablation

Overview

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.

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

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Sadeer Alzubaidi, M.D.

Closed for enrollment

More information

Publications

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