This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
The device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of needle, as well as in verification of needle position during CT guided percutaneous ablation procedures. After validation of the correct positioning of the needle, the tumor ablation procedure is conducted with a device routinely used by the investigator. The Acquisition of a post-interventional CT-guided image is realized to evaluate adverse events occurrence.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Robotic platform for needle placement
Chu Montpellier
Montpellier, France
Gustave Roussy Institut
Villejuif, France
Evaluation of the safety related to the procedure
Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure
Time frame: During the procedure
Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached
Number of targets reached; the target is considered to have been reached when the needle is positioned accurately enough to allow the next step of the procedure to be carried out
Time frame: During the procedure
Evaluation of the accuracy of the device
Assessment of the needle placement accuracy (distance from the needle tip to the target)
Time frame: Through study completion, an average of 1 month
Evaluation of the needle readjustments of the device
Assessment of the number of needle readjustments to reach the target
Time frame: During the procedure
Evaluation of the safety not related to the procedure
All Adverse Event(s) except those considered major and are attributable to the needle insertion phase of the procedure
Time frame: Through study completion, an average of 1 month
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