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| Name | Class |
|---|---|
| ICUREsearch | INDUSTRY |
| Endpoint, LLC | UNKNOWN |
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The goal of this investigational device exemption is to evaluate the Epione assistance for introducer placement during percutaneous procedures in musculo-skeletic (MSK) structures of the pelvis and the spine in adults.
The main question is the determination of the rate of feasible procedures assisted by the Epione device
Participants will undergo their procedure(s) as planned by their physician. If they accept to participate to the study, the differences with standard of care will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT guidance | Experimental | The procedure is performed under CT guidance. |
|
| CBCT guidance | Experimental | The procedure is performed under CBCT guidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous procedure in the MSK structures of the pelvis and/or the spine | Device | The introducer placement is performed with the Epione device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasability | Rate of successful insertions of the introducer with the assistance of the Epione device. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Adverse Event | Adverse event(s) (AE): all AEs (serious and non-serious, related and not related to the device or the procedure(s)) | 6 months |
| Accuracy | Lateral and 3D deviations, being the distance (mm) between the tip of the inserted introducer in its final position and its orthogonal projection on the first planned trajectory (lateral deviation) and the distance (mm) between the tip of the inserted introducer in its final position and the tip of the first planned trajectory (3D deviation). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laetitia Messner | Contact | 305 731-2901 | +1 | clinical.department@quantumsurgical.com |
| Marion Chassouant | Contact | 448 19 40 50 | +33 | clinical.department@quantumsurgical.com |
| Name | Affiliation | Role |
|---|---|---|
| Sean Tutton, MD | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego | Not yet recruiting | San Diego | California | 92093 | United States |
Age, Sex, Ethnicity, Race will be shared
by the end of the study
everyone, they will be described in the report and publication
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 5 months |
| Baptist Hospital Of Miami, Inc | Recruiting | Miami | Florida | 33176 | United States |
|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
|
| D001851 |
| Bone Diseases, Metabolic |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |