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

NCT04230642 | Completed

• 1 other identifier: QS-IS-G-H-1901
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Tumor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Evaluation of the accuracy of the device

  Through study completion, an average of 1 month

• Evaluation of the needle readjustments of the device

  During the procedure

• Evaluation of the safety not related to the procedure

  Through study completion, an average of 1 month

Study Arms (1)

Robotic device

EXPERIMENTAL

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

Device: The Quantum Surgical device

Interventions

The Quantum Surgical device DEVICE

Robotic platform for needle placement

Robotic device

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quantum Surgical: lead

Study Sites (2)

Chu Montpellier

Montpellier, 34000, France

Location

Gustave Roussy Institut

Villejuif, 94000, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Boris Guiu, MD

  Head of radiology department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: May 25, 2020
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)