Trial Outcomes & Findings for EPIONE Guided Lung Evaluation (NCT NCT05651867)

Results Overview

Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

an average of 7 months

Results posted on

2025-07-15

Participant Flow

25 patients included from 2022-11-30 to 2023-08-25 at the IGR (Villejuif/France).

Participant milestones

Participant milestones
Measure	Interventional Arm Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device
Overall Study STARTED	25
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EPIONE Guided Lung Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional Arm n=27 lesions Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device
Age, Continuous	64.2 years STANDARD_DEVIATION 9.4 • n=25 Participants
Sex: Female, Male Female	7 Participants n=25 Participants
Sex: Female, Male Male	18 Participants n=25 Participants
Body Mass Index	25.2 kg/m^2 STANDARD_DEVIATION 4.8 • n=25 Participants

PRIMARY outcome

Timeframe: an average of 7 months

Population: All screened patients who have confirmed their signed informed consent and are planned to be treated using the EPIONE® device.

Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.

Outcome measures

Outcome measures
Measure	Interventional Arm n=27 Number of targets reached Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device EPIONE 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.
Feasibility of the Device	26 Number of targets reached

SECONDARY outcome

Timeframe: an average of 7 months

Population: all patients whose procedure was feasible

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

Outcome measures

Outcome measures
Measure	Interventional Arm n=30 needles Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device EPIONE 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.
Needle Placement Accuracy	1.2 mm Standard Deviation 2.1

SECONDARY outcome

Timeframe: an average of 7 months

Population: all patients whose procedure was feasible

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

Outcome measures

Outcome measures
Measure	Interventional Arm n=30 needle Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device EPIONE 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.
Number of Needle Adjustments	0.8 number of adjustments per needle Standard Deviation 0.5

SECONDARY outcome

Timeframe: an average of 1 year

Population: all patients whose procedure was feasible

If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success

Outcome measures

Outcome measures
Measure	Interventional Arm n=26 lesions Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device EPIONE 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.
Post-intervention Ablation Success	20 lesions

SECONDARY outcome

Timeframe: through study completion, an average of 1 year

Population: all patients whose procedure was feasible and were still in the study after 12 months

If a tumor progresses locally 12 months after the initial treatment, the long-term efficacy of the ablation is considered failed. We count here the patient treated for which the lesion ablated did not show recurrence after 12 months.

Outcome measures

Outcome measures
Measure	Interventional Arm n=19 Participants Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device EPIONE 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.
Long-term Efficacy of Ablation	18 Participants

SECONDARY outcome

Timeframe: through study completion, an average of 21 months

Population: all patients included in the study

number of patients experiencing a serious adverse event

Outcome measures

Outcome measures
Measure	Interventional Arm n=25 Participants Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device EPIONE 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.
Adverse Event	5 participants

SECONDARY outcome

Timeframe: an average of 7 months

Population: all patients who started the procedure with EPIONE

Description of the grade of needle adjustement : minor meaning depth needle adjustment only, medium meaning at lateral needle adjustement (+ or - depth adjustement) or major (meaning complete removal of the needle from the atient body)

Outcome measures

Outcome measures
Measure	Interventional Arm n=31 needle Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device EPIONE 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.
Grade of Needle Adjustment minor adjutsments	7 needle
Grade of Needle Adjustment medium adjustements	17 needle
Grade of Needle Adjustment major adjustements	1 needle
Grade of Needle Adjustment no adjustement	6 needle

Adverse Events

Interventional Arm

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Interventional Arm n=25 participants at risk Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	16.0% 4/25 • Number of events 4 • through study completion, an average of 21 months
Infections and infestations ABCESS	4.0% 1/25 • Number of events 1 • through study completion, an average of 21 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	4.0% 1/25 • Number of events 1 • through study completion, an average of 21 months
Respiratory, thoracic and mediastinal disorders pneumapathy	4.0% 1/25 • Number of events 1 • through study completion, an average of 21 months

Other adverse events

Other adverse events
Measure	Interventional Arm n=25 participants at risk Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device
Respiratory, thoracic and mediastinal disorders Pneumothorax	24.0% 6/25 • Number of events 6 • through study completion, an average of 21 months
Vascular disorders Haemorrhage	8.0% 2/25 • Number of events 2 • through study completion, an average of 21 months

Additional Information

Marion Chassouant

Quantum Surgical

Phone: 0033781425198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place