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| Name | Class |
|---|---|
| PrimeVigilance | INDUSTRY |
| Data Investigation Company Europe (DICE) | UNKNOWN |
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An study evaluating the long-term safety of all patients previously treated with NVDX3.
An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the "core NVDX3 trial"). All patients having signed the ICF enter the long term follow-up study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVDX3 implant | Experimental | NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size/intervertebral disc space. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVDX3 | Drug | NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety of the NVDX3 implant | Description of all SAEs, NVDX3 related AEs and AE of special interest | Between screening (V0) and 120 months post-core study (V10) |
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Inclusion Criteria:
Exclusion Criteria:
No exclusion criteria are applicable.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denis Dufrane, MD | Contact | +3210779220 | clinical@novadip.com | |
| Danielle Gérard, MSc | Contact | +32473540008 | danielle.gerard@novadip.com |
| Name | Affiliation | Role |
|---|---|---|
| Torsten Gerich, MD | Centre Hospitalier du Luxembourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Luxembourg | Recruiting | Luxembourg | 1210 | Luxembourg |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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