Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement

Multicenter Study to Evaluate the Safety and Performance of the Quantum Surgical Robotic Device for Image-guided Percutaneous Needle Placement

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.

Inclusion Criteria:

• Patient is at least 18 years old,
• Patient for whom an ablation procedure under CT guidance in liver organ has been prescribed and consensually agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
• Patient not taking platelet antiaggregant or having stopped taking it for 5 days and not taking anticoagulant (thrombocytes ≥ 50 000/mm3, TP > 50%),
• Patient who agrees to participate in the evaluation and who has signed the inform consent,
• Patient covered by social security system.

Exclusion Criteria:

• Patient unable to undergo general anesthesia,
• Patient unable to tolerate CT contrast agent
• Patient already participating in another clinical study
• Pregnant or breast-feeding woman.