Trial Outcomes & Findings for Epione® Post-Market Clinical Follow-up Study (NCT NCT05529979)

NCT ID: NCT05529979

Last Updated: 2026-01-06

Results Overview

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)

• Recruitment status: COMPLETED
• Target enrollment: 55 participants
• Primary outcome timeframe: Visit 2 - D0 The day of the intervention
• Results posted on: 2026-01-06

Participant Flow

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.

Unit of analysis: tumor lesions

Participant milestones

Measure	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.
Overall Study STARTED	55 62
Overall Study COMPLETED	40 56
Overall Study NOT COMPLETED	15 6

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	6
Overall Study Physician Decision	1
Overall Study non-feasibility cases	4
Overall Study Lack of Efficacy	3
Overall Study ablation not performed	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention With the EPIONE® Device n=54 Participants 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.
Age, Categorical <=18 years	0 Participants n=54 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=54 Participants
Age, Categorical >=65 years	30 Participants n=54 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 12.9 • n=54 Participants
Sex: Female, Male Female	24 Participants n=54 Participants
Sex: Female, Male Male	30 Participants n=54 Participants
Region of Enrollment France	54 participants n=54 Participants

PRIMARY outcome

Timeframe: Visit 2 - D0 The day of the intervention

Population: The Screened, ITT, PP and Safety populations were identical, each comprising 54 patients

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)

Outcome measures

Measure

Intervention With the EPIONE® Device n=54 Participants 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.

Technical Success

50 Participants

PRIMARY outcome

Timeframe: Visit 2 - D0 The day of the intervention

Population: The Screened, ITT, PP and Safety populations were identical, each comprising 61 lesions.

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)

Outcome measures

Measure

Intervention With the EPIONE® Device n=61 Lesions 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.

Technical Success

56 lesions

SECONDARY outcome

Timeframe: Visit 2 - D0 The day of the intervention

accuracy of the needle placement: deviation between the planned and actual needle position once inserted

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visit 2 - D0 The day of the intervention

Detail of the number/nature of adjustments performed after the initial insertion of the needle

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until Visit 4 - Routine FU visit at 10 months

Minimal Ablation Margin(s) measure(s) if applicable (mm)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until Visit 4 - Routine FU visit at 10 months

Evaluation of the local tumor progression following the ablation (if applicable)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visit 2 - D0 The day of the intervention

5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until Visit 4 - Routine FU visit at 10 months

Safety of the device

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Visit 2 - D0 The day of the intervention

Evaluation of the device dysfunction

Outcome measures

Outcome data not reported

Adverse Events

Intervention With the EPIONE® Device

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention With the EPIONE® Device n=54 participants at risk 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.
Renal and urinary disorders Polynephritis requiring prolonged hospitalization	1.9% 1/54 • Number of events 1 • The safety population is composed of the 54 included patients who were followed until 2 months (88.9% of patients) and 10 months (72,2% of patients). Intensity, Category, Action, Causality, outcome, patient and procedural risk modifier, adverse event preventability and management of each adverse event were classified according to SIR classification (Khalilzadeh and al.2017 / Sacks and al.2003). The adverse event category (serious or not) was from the ISO 14155-1.
Infections and infestations Hospitalization for large abscess in the thermoablation area, requiring drainage	1.9% 1/54 • Number of events 1 • The safety population is composed of the 54 included patients who were followed until 2 months (88.9% of patients) and 10 months (72,2% of patients). Intensity, Category, Action, Causality, outcome, patient and procedural risk modifier, adverse event preventability and management of each adverse event were classified according to SIR classification (Khalilzadeh and al.2017 / Sacks and al.2003). The adverse event category (serious or not) was from the ISO 14155-1.
Respiratory, thoracic and mediastinal disorders Hemorrhagic pleural effusion	1.9% 1/54 • Number of events 1 • The safety population is composed of the 54 included patients who were followed until 2 months (88.9% of patients) and 10 months (72,2% of patients). Intensity, Category, Action, Causality, outcome, patient and procedural risk modifier, adverse event preventability and management of each adverse event were classified according to SIR classification (Khalilzadeh and al.2017 / Sacks and al.2003). The adverse event category (serious or not) was from the ISO 14155-1.

Other adverse events

Measure	Intervention With the EPIONE® Device n=54 participants at risk 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.
Surgical and medical procedures Adjacent structure thermal lesion	1.9% 1/54 • Number of events 1 • The safety population is composed of the 54 included patients who were followed until 2 months (88.9% of patients) and 10 months (72,2% of patients). Intensity, Category, Action, Causality, outcome, patient and procedural risk modifier, adverse event preventability and management of each adverse event were classified according to SIR classification (Khalilzadeh and al.2017 / Sacks and al.2003). The adverse event category (serious or not) was from the ISO 14155-1.
Surgical and medical procedures Fever	3.7% 2/54 • Number of events 2 • The safety population is composed of the 54 included patients who were followed until 2 months (88.9% of patients) and 10 months (72,2% of patients). Intensity, Category, Action, Causality, outcome, patient and procedural risk modifier, adverse event preventability and management of each adverse event were classified according to SIR classification (Khalilzadeh and al.2017 / Sacks and al.2003). The adverse event category (serious or not) was from the ISO 14155-1.
Respiratory, thoracic and mediastinal disorders Pneumothorax with drainage	1.9% 1/54 • Number of events 1 • The safety population is composed of the 54 included patients who were followed until 2 months (88.9% of patients) and 10 months (72,2% of patients). Intensity, Category, Action, Causality, outcome, patient and procedural risk modifier, adverse event preventability and management of each adverse event were classified according to SIR classification (Khalilzadeh and al.2017 / Sacks and al.2003). The adverse event category (serious or not) was from the ISO 14155-1.

Additional Information

MESSNER Laetitia, Chief Clinical officer

quantum surgical

Phone: 0448194050

Email: clinical.department@quantumsurgical.com

Results disclosure agreements

• Principal investigator is a sponsor employee From the protocol: "Prior to submitting the results of this study for publication or presentation, the Investigator will allow the Sponsor 30 days in which to review and comment upon the publication manuscript. The Sponsor agrees that before he publishes any results of this study, he shall provide the Investigators at least 30 days for full review of the publication manuscript"
• Publication restrictions are in place

Restriction type: OTHER