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Recruiting

NCT Number: NCT06532253

Long-term Safety Trial with NVDX3

An study evaluating the long-term safety of all patients previously treated with NVDX3.

Recruiting

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Key information

Conditions

Distal Radius Fractures Arm Injuries Degenerative Lumbar Spondylolisthesis Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre Hospitalier de Luxembourg

Luxembourg, 1210

Location status: Recruiting

Location contact

Torsten Gerich, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

No exclusion criteria are applicable.

Treatment and study plan

NVDX3

Drug

NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)

Primary outcomes

  1. Long-term safety of the NVDX3 implant

    Time frame: Between screening (V0) and 120 months post-core study (V10)

    Description of all SAEs, NVDX3 related AEs and AE of special interest

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Gérard, MSc

CONTACT

[email protected]

+32473540008

Denis Dufrane, MD

CONTACT

[email protected]

+3210779220

Sponsors and collaborators

Lead sponsor

Novadip Biosciences

Industry

Collaborators

  • Data Investigation Company Europe (DICE)
  • PrimeVigilance

Registry information

Official study title

Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.

Acronym: X3LTFU

Important dates

Study start
2024
Primary completion
2036
Study completion
2036
First posted
Aug 1, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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