Long-term Safety Trial with NVDX3 (X3LTFU)

September 1, 2024 updated by: Novadip Biosciences

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVDX3 implant
Drug: NVDX3
NVDX3 is implanted during a single surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between screening (V0) and 120 months post-core study (V10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novadip Biosciences

Collaborators

PrimeVigilance
Data Investigation Company Europe (DICE)

Investigators

  • Principal Investigator: Torsten Gerich, MD, Centre Hospitalier du Luxembourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Estimated)

March 1, 2036

Study Completion (Estimated)

March 1, 2036

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVDX3-CLN0X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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