Epione® Post-Market Clinical Follow-up Study

NCT05529979 | Completed Results

• 1 other identifier: QS-NIS-G-H-2101
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen

Conditions

Cancer Abdomen

Keywords

Percutaneous; CT-guided; Ablation; Biopsy; Abscess Drainage; Fiducial Placement; Abdomen; Liver; Kidney; Robotics

Outcome Measures

Primary Outcomes (2)

• Technical Success

  Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by patient)

  Visit 2 - D0 The day of the intervention

• Technical Success

  Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed (by lesion)

  Visit 2 - D0 The day of the intervention

Secondary Outcomes (7)

• Needle Placement Accuracy

  Visit 2 - D0 The day of the intervention

• Number and Nature of Needle Adjustments to Reach the Target

  Visit 2 - D0 The day of the intervention

• Post-intervention Ablation Success

  Until Visit 4 - Routine FU visit at 10 months

• Local Tumor Recurrence

  Until Visit 4 - Routine FU visit at 10 months

• Operator Satisfaction

  Visit 2 - D0 The day of the intervention

Study Arms (1)

Intervention with the EPIONE® device

Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device

Device: EPIONE® CT-Guided Percutaneous procedures

Interventions

EPIONE® CT-Guided Percutaneous procedures DEVICE

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

Intervention with the EPIONE® device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated/operated in routine practice, in accordance with the device's intended use, without any additional nor burdensome procedure.

You may qualify if:

• Patient \>18 years old,
• Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
• Patient with a confirmed non-opposition.

You may not qualify if:

• Patient unable to undergo general anesthesia,
• Pregnant or breast-feeding females

Sponsors & Collaborators

• Quantum Surgical: lead

Study Sites (1)

Gustave Roussy Institut

Villejuif, 94000, France

Location

Results Point of Contact

• Title: MESSNER Laetitia, Chief Clinical officer
• Organization: quantum surgical

clinical.department@quantumsurgical.com

0448194050

Study Officials

• Baptiste BONNET, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: September 7, 2022
• Study Start: April 28, 2022
• Primary Completion: February 22, 2023
• Study Completion: April 27, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)