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

Not Applicable

Completed

• Conditions: Hepatic Tumor
• Interventions: Device: The Quantum Surgical device

• Registration Number: NCT04230642
• Lead Sponsor: Quantum Surgical

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2020-05-25
• Status Verified: 2021-02
• Primary Completion: 2021-02-02
• Study Completion: 2021-02-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic device	The Quantum Surgical device	Needle placement to the tumor, one time, the day of the ablation procedure

Primary Outcome Measures

Name	Time	Method
Evaluation of the feasibility of the Quantum Surgical device: Number of targets reached	During the procedure	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
Evaluation of the safety related to the procedure	During the procedure	Number of Adverse Event(s) that are considered to be major and are attributable to the needle insertion phase of the procedure

Secondary Outcome Measures

Name	Time	Method
Evaluation of the needle readjustments of the device	During the procedure	Assessment of the number of needle readjustments to reach the target
Evaluation of the accuracy of the device	Through study completion, an average of 1 month	Assessment of the needle placement accuracy (distance from the needle tip to the target)
Evaluation of the safety not related to the procedure	Through study completion, an average of 1 month	All Adverse Event(s) except those considered major and are attributable to the needle insertion phase of the procedure

Trial Locations

Locations (2)

Gustave Roussy Institut; 🇫🇷 Villejuif, France

Chu Montpellier; 🇫🇷 Montpellier, France