Long-term safety evaluation of NVDX3 treatment
Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.
This study is testing the long-term safety of the NVDX3 treatment in patients who have already received it, by checking in with them every year for 10 years to see if they experience any problems.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Novadip Biosciences Industry-sponsored |
| Locations | 1 site (Luxembourg) |
| Trial ID | NCT06532253 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term safety of patients who have previously been treated with NVDX3, focusing on those who participated in earlier core clinical trials. Participants will undergo yearly follow-up safety visits for a duration of 10 years to monitor any potential adverse effects or complications associated with the treatment. The study aims to gather comprehensive safety data to ensure the well-being of patients over an extended period.
Who should consider this trial
Good fit: Ideal candidates are patients who have previously been treated with NVDX3 and are willing to commit to long-term follow-up.
Not a fit: Patients who have not been treated with NVDX3 or those unwilling to participate in long-term follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety of NVDX3, enhancing patient confidence in its use.
How similar studies have performed: While this study focuses on long-term safety, similar studies evaluating the safety of treatments have shown success in providing critical data for patient management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient being implanted with NVDX3. 2. Previously participated to one of the NVDX3 core clinical trials. 3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years 4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent. Exclusion Criteria: No exclusion criteria are applicable.
Where this trial is running
Luxembourg
- Centre Hospitalier de Luxembourg — Luxembourg, Luxembourg (Recruiting)
Study contacts
- Principal investigator: Torsten Gerich, MD — Centre Hospitalier du Luxembourg
- Study coordinator: Denis Dufrane, MD
- Email: clinical@novadip.com
- Phone: +3210779220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.