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EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy
NA trial testing CT-guided bone percutaneous procedure in Bone Metastases in 34 participants. Completed in 6 January 2025.
| Lead sponsor | Quantum Surgical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 16 September 2024 |
| Primary completion | 29 November 2024 |
| Estimated completion | 6 January 2025 |
| Sites | 3 locations across France |
Quantum Surgical
18 and older, any sex, with Bone Metastases or Fractures, Bone. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To evaluate the feasibility of the EPIONE robotic assistance for bone percutaneous procedures based on a definition of conversion to manual technique
| Group | Value | 95% CI |
|---|---|---|
| Interventional Arm | 89 |
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))
| Group | Value | 95% CI |
|---|---|---|
| Interventional Arm | 6 |
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
| Group | Value | 95% CI |
|---|---|---|
| Interventional Arm | 2.00 | ± 1.41 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Interventional Arm | 3.06 | ± 2.74 |
Time frame: Up to 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Interventional Arm |
|---|---|---|
| Clinical deterioration | Musculoskeletal and connective tissue disorders | — |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | — |
| Heart decompensated failure | Cardiac disorders | — |
| Clinical deterioration | Musculoskeletal and connective tissue disorders | — |
| Reaction | System | Interventional Arm |
|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | — |
| Alteration of general condition, nausea and vomiting | Musculoskeletal and connective tissue disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Clinical deterioration, Respiratory distress, Heart decompensated failure, Clinical deterioration.
Data from ClinicalTrials.gov NCT06376682 adverse events section.
Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06376682.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing