CompletedPhase 1/2

Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.

Luxembourg11 participantsStarted 2023-08-08

Plain-language summary

Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female patients within the age range of ≥18 years to ≤80 years.
. Patient diagnosed with DRF with confirmed:
. Classification AO/ATO: C2 and C3 - Intra-articular \& multifragmentation.
. Estimated volume of the targeted bone void should not exceed 5cc.
. Availability of diagnostic AP and LAT X-ray or CT scan.
. Patient can undergo the targetted surgical intervention within 7 days post-DRF diagnosis.
. Patient fulfills criteria for undergoing a surgical intervention.
. Patient has understood and accepted to participate in the study according to all study procedures by signing the informed consent.

Exclusion criteria

. Open DRF or closed DRF with increased infection risk.
. Injury to the median nerve.
. Previous fracture of the target distal radius.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety: Serious Treatment-emergent Adverse Events (TEAEs) and NVDX3-related TEAEs

Timeframe: Between the beginning of the implant surgery (IS) and 12 months post-IS

Trial details

NCT IDNCT05987033

SponsorNovadip Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-19

Results submitted2026-01-12

View on ClinicalTrials.gov More Distal Radius Fractures trials