Cancer Abdomen
Conditions
Keywords
Percutaneous, CT-guided, Ablation, Biopsy, Abscess Drainage, Fiducial Placement, Abdomen, Liver, Kidney, Robotics
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
Detailed description
The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen. The objectives are: 1. to evaluate the technical success of the device 2. to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device 55 patients are planned in this post-market study.
Interventions
DEVICEEPIONE® CT-Guided Percutaneous procedures
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.
Sponsors
Quantum Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patient unable to undergo general anesthesia, * Pregnant or breast-feeding females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Visit 2 - D0 The day of the intervention | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Recurrence | Until Visit 4 - Routine FU visit at 10 months | Evaluation of the local tumor progression following the ablation (if applicable) |
| Operator Satisfaction | Visit 2 - D0 The day of the intervention | 5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied |
| Adverse Events Related to Device or Procedure | Until Visit 4 - Routine FU visit at 10 months | Safety of the device |
| Post-intervention Ablation Success | Until Visit 4 - Routine FU visit at 10 months | Minimal Ablation Margin(s) measure(s) if applicable (mm) |
| Number and Nature of Needle Adjustments to Reach the Target | Visit 2 - D0 The day of the intervention | Detail of the number/nature of adjustments performed after the initial insertion of the needle |
| Device Dysfunction | Visit 2 - D0 The day of the intervention | Evaluation of the device dysfunction |
| Needle Placement Accuracy | Visit 2 - D0 The day of the intervention | accuracy of the needle placement: deviation between the planned and actual needle position once inserted |
Countries
France
Participant flow
Recruitment details
55 patients were included (28-Apr-2022 and 20-Jan-2023) at the IGR (Villejuif/France). The date of the last patient FU visit is 27-APR-2024.
Participants by arm
| Arm | Count |
|---|---|
| Intervention With the EPIONE® Device Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device
EPIONE® CT-Guided Percutaneous procedures: 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. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | ablation not performed | 1 |
| Overall Study | Lack of Efficacy | 3 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | non-feasibility cases | 4 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Intervention With the EPIONE® Device | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 30 Participants | — |
| Age, Categorical Between 18 and 65 years | 24 Participants | — |
| Age, Continuous | 64.7 years STANDARD_DEVIATION 12.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 54 participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 4 / 54 |
| serious Total, serious adverse events | 3 / 54 |
Outcome results
Primary
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)
Time frame: Visit 2 - D0 The day of the intervention
Population: The Screened, ITT, PP and Safety populations were identical, each comprising 61 lesions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention With the EPIONE® Device | Technical Success | 56 lesions |
Primary
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)
Time frame: Visit 2 - D0 The day of the intervention
Population: The Screened, ITT, PP and Safety populations were identical, each comprising 54 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention With the EPIONE® Device | Technical Success | 50 Participants |
Secondary
Adverse Events Related to Device or Procedure
Safety of the device
Time frame: Until Visit 4 - Routine FU visit at 10 months
Secondary
Device Dysfunction
Evaluation of the device dysfunction
Time frame: Visit 2 - D0 The day of the intervention
Secondary
Local Tumor Recurrence
Evaluation of the local tumor progression following the ablation (if applicable)
Time frame: Until Visit 4 - Routine FU visit at 10 months
Secondary
Needle Placement Accuracy
accuracy of the needle placement: deviation between the planned and actual needle position once inserted
Time frame: Visit 2 - D0 The day of the intervention
Secondary
Number and Nature of Needle Adjustments to Reach the Target
Detail of the number/nature of adjustments performed after the initial insertion of the needle
Time frame: Visit 2 - D0 The day of the intervention
Secondary
Operator Satisfaction
5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied
Time frame: Visit 2 - D0 The day of the intervention
Secondary
Post-intervention Ablation Success
Minimal Ablation Margin(s) measure(s) if applicable (mm)
Time frame: Until Visit 4 - Routine FU visit at 10 months