Clinical trial NCT04970212: Safety and Effectiveness of BioTraceIO Lite for Tissue Damage Assessment Following Liver Tissue Ablation Procedures
Official title: Pivotal Clinical Study to Establish the Safety and Effectiveness of the Use of BioTraceIO Lite for Assessment of Tissue Damage Following Liver Tissue Ablation Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Hepatocellular
Metastatic Liver Cancer
Lead sponsor: Techsomed Medical Technologies LTD
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have been scheduled to have a liver ablation as part of their clinical care.

Brief summary: Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) CECT scan and that it is safe, based on an assessment of device-related Adverse Events.

Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).

Detailed description: Clinical study planned to demonstrate that the BioTraceIO Lite, available post-procedure, is effective at estimating the area of tissue damage as measured on 24-hour post-procedure (T=24hrs) contrast-enhanced CT scan and that it is safe, based on an assessment of device-related Adverse Events.

BioTraceIO Lite is intended to provide physicians with adjunctive information in their clinical assessment of tissue damage created by liver tissue ablation, as part of their overall post-procedure clinical assessment.

Multi-center (up to 6 investigational sites) prospective single-arm clinical investigation 50 evaluable subjects total stratified by cancer type (primary hepatocellular carcinoma vs. secondary liver metastases).

Eligibility criteria: Inclusion Criteria:

1. Scheduled and indicated for standard-of-care liver tissue ablation for either hepatocellular carcinoma (HCC) or metastatic liver tumor(s) using either RF or MW energy.
2. At least 21 years of age
3. 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.
4. 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.
5. Single ablation, using a single ablation needle, per tumor.
6. Able and willing to give informed consent.

Exclusion Criteria:

1. Liver tumor that cannot be ablated with a single ablation needle, according to the investigator's clinical opinion.
2. Subject cannot tolerate/undergo contrast-enhanced CT.
3. 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.
4. Ablation area cannot be visualized continuously using ultrasound throughout the entire ablation procedure.
5. Pregnant or lactating
6. Currently participating in another clinical trial of an unapproved investigational device or drug that has not concluded the follow-up period.
7. Unable or unwilling to give informed consent.

Primary outcomes:
measure: Safety - Adverse Events
timeFrame: 1 year
measure: Effectiveness - DICE
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity
timeFrame: 1 year
measure: Precision
timeFrame: 1 year
measure: Questionnaire - Effect of BioTraceIO
timeFrame: 1 year
measure: Difference between T=0 and T=24hrs CECT tissue damage
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Stanford
country: United States
facility: Stanford Medicine
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: University Hospitals Cleveland
state: Ohio
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References: