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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-16

Study Completion Date

2025-01-06

Brief Summary

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Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.

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Detailed Description

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The objectives are:

1. To evaluate the feasibility of the Epione robotic assistance for bone percutaneous procedures.
2. To evaluate the safety and the accuracy of the Epione robotic assistance for bone percutaneous procedures.

At least 34 patients (representing at least 67 insertions, as one patient may undergo one or more insertions during the procedure) have been planned for the study. They will be treated by the clinician using the Epione device during a CT-guided percutaneous procedure in musculoskeletal (MSK) structures.

Conditions

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Bone Metastases Fractures, Bone Bone Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional arm

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

Group Type EXPERIMENTAL

CT-guided bone percutaneous procedure

Intervention Type PROCEDURE

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 (thermal ablation, bone consolidation, biopsy procedures).

Interventions

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CT-guided bone percutaneous procedure

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 (thermal ablation, bone consolidation, biopsy procedures).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient ≥18 years,
2. Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
3. Patient who has signed an informed consent form,
4. Patient covered by a social security system,

Exclusion Criteria

1. Patient with contraindication to general anaesthesia,
2. Patient undergoing a procedure without appropriate breathing control,
3. Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
4. Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
5. Pregnant or breast-feeding women,
6. Patient under legal protection (tutorship, guardianship, …),
7. Patient already participating in another interventional clinical study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No