Long-term Safety Trial with NVDX3
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovadip Biosciences
About this trial
An study evaluating the long-term safety of all patients previously treated with NVDX3.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient being implanted with NVDX3.
Previously participated to one of the NVDX3 core clinical trials.
Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
NVDX3
DrugNVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: NVDX3 implantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Novadip Biosciences
Lead sponsor
PrimeVigilance
Collaborator
Data Investigation Company Europe (DICE)
Collaborator
Source ClinicalTrials.gov