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.

Study Overview

• Status: Completed
• Conditions: Hepatic Tumor
• Intervention / Treatment: Device: The Quantum Surgical device

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34000
    • CHU Montpellier
  • Villejuif, France, 94000
    • Gustave Roussy Institut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Quantum Surgical
• Investigators: Principal Investigator: Boris Guiu, MD, Head of radiology department

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): February 2, 2021
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: QS-IS-G-H-1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No