Trial Outcomes & Findings for EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy (NCT NCT06376682)

Results Overview

To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Day of the procedure

Results posted on

2025-09-22

Participant Flow

Enrollment occurred bewteen 16-SEP-2024 and 29-NOV-2024 in the 3 sites. Across the 34 patients included, 90 CT-guided insertions were performed (mean of 2.6 insertions per patient (range: 1-7)).

Unit of analysis: Insertion

Participant milestones

Participant milestones
Measure	Interventional Arm Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Overall Study STARTED	34 90
Overall Study COMPLETED	32 84
Overall Study NOT COMPLETED	2 6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional Arm n=90 Insertion Patients treated by CT-guided percutaneous procedures in the bone with the EPIONE® device
Age, Continuous	64.3 years STANDARD_DEVIATION 14.5 • n=34 Participants
Sex: Female, Male Patients · Female	20 Participants n=34 Participants
Sex: Female, Male Patients · Male	14 Participants n=34 Participants
Region of Enrollment France	34 participants n=34 Participants
Body Mass Index	24.4 Kg/m^2 STANDARD_DEVIATION 4.4 • n=34 Participants

PRIMARY outcome

Timeframe: Day of the procedure

To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique

Outcome measures

Outcome measures
Measure	Interventional Arm n=90 Insertions Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Successful Introducer Insertion With the EPIONE Device.	89 Successful insertion

SECONDARY outcome

Timeframe: Up to 1 month

To evaluate the safety of the EPIONE robotic assistance for bone percutaneous procedures: all AEs (serious and non-serious, related and not-related to the device or the procedure(s))

Outcome measures

Outcome measures
Measure	Interventional Arm n=34 Participants Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Adverse Event(s) (AE)	6 Participants

SECONDARY outcome

Timeframe: Day of the procedure

Population: Accuracy was measured by insertion. A patient could have multiple introducer insertions during his procedure.

To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Lateral deviation: distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory

Outcome measures

Outcome measures
Measure	Interventional Arm n=90 Bone introducer insertions Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures	2.00 mm Standard Deviation 1.41

SECONDARY outcome

Timeframe: Day of the procedure

Population: Accuracy was measured by insertion. A patient could have multiple introducer insertions during his procedure.

To evaluate the accuracy of the EPIONE robotic assistance for bone percutaneous procedures. Angular deviation (°): 3D angle between the inserted introducer in its final position and the first planned trajectory.

Outcome measures

Outcome measures
Measure	Interventional Arm n=90 Bone introducer insertions Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Angular Deviation (°)	3.06 ° Standard Deviation 2.74

Adverse Events

Interventional Arm

Serious events: 4 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Interventional Arm n=34 participants at risk Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Musculoskeletal and connective tissue disorders Clinical deterioration	2.9% 1/34 • Number of events 1 • Up to 1 month * AE definitions are based on the ISO 14155:2020 * AE intensity is based on the standardized Society of Interventional Radiology (SIR) classification. * Safety data are reviewed by a Data Safety Monitoring Board (DSMB)
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.9% 1/34 • Number of events 1 • Up to 1 month * AE definitions are based on the ISO 14155:2020 * AE intensity is based on the standardized Society of Interventional Radiology (SIR) classification. * Safety data are reviewed by a Data Safety Monitoring Board (DSMB)
Cardiac disorders Heart decompensated failure	2.9% 1/34 • Number of events 1 • Up to 1 month * AE definitions are based on the ISO 14155:2020 * AE intensity is based on the standardized Society of Interventional Radiology (SIR) classification. * Safety data are reviewed by a Data Safety Monitoring Board (DSMB)

Other adverse events

Other adverse events
Measure	Interventional Arm n=34 participants at risk Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device
Musculoskeletal and connective tissue disorders Pain	2.9% 1/34 • Number of events 1 • Up to 1 month * AE definitions are based on the ISO 14155:2020 * AE intensity is based on the standardized Society of Interventional Radiology (SIR) classification. * Safety data are reviewed by a Data Safety Monitoring Board (DSMB)
Musculoskeletal and connective tissue disorders Alteration of general condition, nausea and vomiting	2.9% 1/34 • Number of events 1 • Up to 1 month * AE definitions are based on the ISO 14155:2020 * AE intensity is based on the standardized Society of Interventional Radiology (SIR) classification. * Safety data are reviewed by a Data Safety Monitoring Board (DSMB)
Respiratory, thoracic and mediastinal disorders Dyspnea	2.9% 1/34 • Number of events 1 • Up to 1 month * AE definitions are based on the ISO 14155:2020 * AE intensity is based on the standardized Society of Interventional Radiology (SIR) classification. * Safety data are reviewed by a Data Safety Monitoring Board (DSMB)

Additional Information

MESSNER Laetitia, Chief Clinical officer

quantum surgical

Phone: +33 (0) 4 48 19 40 50

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee As mentionned in the protocol: "Prior to submitting the results of this study for publication or presentation, the investigator will have to receive the formal validation by the sponsor on the publication manuscript or presentation. In accordance with generally recognized principles of scientific collaboration, co-authorship with any sponsor personnel will be discussed and mutually agreed upon before submission of a manuscript to a publisher".
Publication restrictions are in place

Restriction type: OTHER