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

NCT ID: NCT04230642

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-25
• Study Completion Date: 2021-02-02

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.

Conditions

Hepatic Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic device

Needle placement to the tumor, one time, the day of the ablation procedure

Group Type: EXPERIMENTAL

The Quantum Surgical device

Intervention Type: DEVICE

Robotic platform for needle placement

Interventions

The Quantum Surgical device

Robotic platform for needle placement

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quantum Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boris Guiu, MD

Role: PRINCIPAL_INVESTIGATOR

Head of radiology department

Locations

Chu Montpellier

Montpellier, , France

Gustave Roussy Institut

Villejuif, , France

Countries

France

Other Identifiers

QS-IS-G-H-1901

Identifier Type: -

Identifier Source: org_study_id