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

Quantum Surgical

Status

Completed

Conditions

Hepatic Tumor

Treatments

Device: The Quantum Surgical device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04230642

QS-IS-G-H-1901

Details and patient eligibility

About

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.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

18+ months old

Volunteers

No Healthy Volunteers

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