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| Name | Class |
|---|---|
| ICUREsearch | INDUSTRY |
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Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
The objectives are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-guided bone percutaneous procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Introducer Insertion With the EPIONE Device. | To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique | Day of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(s) (AE) | 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)) | Up to 1 month |
| Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Baptiste BONNET | Gustave Roussy Cancer Institute | Principal Investigator |
| Nicolas STACOFFE | Hospices Civils de Lyon | Principal Investigator |
| Gilles PIANA | Paoli-Calmettes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | 69000 | France | |||
| Institut Paoli-Calmettes |
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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)).
| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Arm | Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Arm | Patients treated by CT-guided percutaneous procedures in the bone with the EPIONE® device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Successful Introducer Insertion With the EPIONE Device. | To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique | Posted | Number | Successful insertion | Day of the procedure | Insertions | Insertions |
|
|
Up to 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Arm | Patients treated by percutaneous CT-guided procedures in the bone with the EPIONE® device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinical deterioration | Musculoskeletal and connective tissue disorders | Not specifically | Non-systematic Assessment | Death at day 9 after the procedure due to cancer progression not related to the procedure, not related to the device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | Not specifically | Non-systematic Assessment | Increased right cervical and scapular pain at day 46 after the procedure without deficit in metastatic renal cell carcinoma. Not related to the procedure, not related to the device. Resolved at day 47. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MESSNER Laetitia, Chief Clinical officer | quantum surgical | +33 (0) 4 48 19 40 50 | clinical.department@quantumsurgical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2024 | Aug 12, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 5, 2025 | Aug 12, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
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The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures.
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|
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 |
| Day of the procedure |
| Angular Deviation (°) | 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. | Day of the procedure |
| Marseille |
| 13000 |
| France |
| Institut Gustave Roussy | Villejuif | 94800 | France |
| Insertion |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | No | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Body Mass Index | Mean | Standard Deviation | Kg/m^2 | Participants |
|
|
| Insertions |
|
|
| Secondary | Adverse Event(s) (AE) | 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)) | Posted | Count of Participants | Participants | Up to 1 month |
|
|
|
| Secondary | Lateral Deviation (mm) Accuracy of the EPIONE Robotic Assistance for Bone Percutaneous Procedures | 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 | Accuracy was measured by insertion. A patient could have multiple introducer insertions during his procedure. | Posted | Mean | Standard Deviation | mm | Day of the procedure | Bone introducer insertions | Bone introducer insertions |
|
|
|
| Secondary | Angular Deviation (°) | 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. | Accuracy was measured by insertion. A patient could have multiple introducer insertions during his procedure. | Posted | Mean | Standard Deviation | ° | Day of the procedure | Bone introducer insertions | Bone introducer insertions |
|
|
|
| 2 |
| 34 |
| 4 |
| 34 |
| 3 |
| 34 |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Not specifically | Non-systematic Assessment | Life-threatening or disabling event/In-patient or prolonged hospitalization at day 18 after the procedure, not related to the device, not related to the procedure. Recovered event. Resolved at D30 |
|
| Heart decompensated failure | Cardiac disorders | Not specifically | Non-systematic Assessment | Left-sided heart decompensated failure at day 13 after the procedure, due to probable post chemotherapy systolic dysfunction of the left ventricule. Not related to the procedure, not related to the device. Recovered Event, Resolved at day 17. |
|
| Clinical deterioration | Musculoskeletal and connective tissue disorders | Not specifically | Non-systematic Assessment | eterioration in general condition and sudden dyspnea. Patient 's death at day 46 after the procedure due to tumor progression. Not related to the procedure, not related to the device. |
|
|
| Alteration of general condition, nausea and vomiting | Musculoskeletal and connective tissue disorders | Not specifically | Non-systematic Assessment | The day of the procedure, not related to the procedure, not related to the device. Favorable evolution with symptomatic treatment. Event Resolved at day 4. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Not specifically | Non-systematic Assessment | Acute dyspnea at day 30 after the procedure in the context of decompensated heart failure and metastatic breast tumor. Not related to the procedure, not related to the device. Event resolved at the end of the study. |
|
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".
| D009140 |
| Musculoskeletal Diseases |