Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
Overview
Tab Title Description
Study type
ObservationalDescribes 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
- Rochester, Minnesota: 21-007465
- Scottsdale/Phoenix, Arizona: 21-007465
NCT ID: NCT04970212
Sponsor Protocol Number: CL000012
About this study
The purpose of the study is to look at the safety and effectiveness of using BioTraceIO Lite software during an ultrasound for patients who are having a liver ablation procedure.
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:
- Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either radiofrequency (RF) or microwave (MW) energy.
- At least 21 years of age.
- 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.
- Single ablation, using a single ablation needle, per tumor.
- Able and willing to give informed consent.
Exclusion Criteria:
- Liver tumor that cannot be ablated with a single ablation needle, according to the investigator’s clinical discretion.
- Subject cannot tolerate/undergo contrast-enhanced CT.
- Planned ablation includes adjunctive means other than RF or MW energy (e.g., ethanol, hepatic artery embolization, etc.) or overlapping ablations using a single ablation needle.
- Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
- Pregnant or lactating.
- 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.
Eligibility last updated 5/24/22. 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Thomas Atwell, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Sadeer Alzubaidi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available