A Phase 1/2 interventional study of NVDX3 in Distal Radius Fractures and Degenerative Lumbar Spondylolisthesis, sponsored by Novadip Biosciences. Recruiting at 1 site in Luxembourg. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Novadip Biosciences · Phase 1/2, Interventional, and Treatment
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.
330 studies on the registry are indexed under Wrist Fractures; 73 are open to participants now.
This study's planned enrollment of 15 is below the median of 62 across 265 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Novadip Biosciences is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No exclusion criteria are applicable.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size/intervertebral disc space.
Drug: NVDX3
NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)
Long-term safety of the NVDX3 implant
Description of all SAEs, NVDX3 related AEs and AE of special interest
Time frame: Between screening (V0) and 120 months post-core study (V10)
Started Aug 2024 (actual). Primary completion is estimated for Mar 2036, 139 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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