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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hepatic Tumor

Intervention / Treatment
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* Device: The Quantum Surgical device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic device<br>Needle placement to the tumor, one time, the day of the ablation procedure | Device: The Quantum Surgical device<br>* Robotic platform for needle placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the accuracy of the device | Assessment of the needle placement accuracy (distance from the needle tip to the target) | 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 | 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 | Through study completion, an average of 1 month |