NCT06532253

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
119mo left

Started Aug 2024

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Aug 2024Mar 2036

First Submitted

Initial submission to the registry

July 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

August 22, 2024

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2036

Last Updated

September 5, 2024

Status Verified

July 1, 2024

Enrollment Period

11.5 years

First QC Date

July 29, 2024

Last Update Submit

September 1, 2024

Conditions

Distal Radius FracturesDegenerative Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • Long-term safety of the NVDX3 implant

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

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

Study Arms (1)

NVDX3 implant

EXPERIMENTAL

NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size/intervertebral disc space.

Drug: NVDX3

Interventions

NVDX3DRUG

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

NVDX3 implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Luxembourg

Luxembourg, 1210, Luxembourg

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Torsten Gerich, MD

    Centre Hospitalier du Luxembourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis Dufrane, MD

CONTACT

+3210779220clinical@novadip.com

Danielle Gérard, MSc

CONTACT

+32473540008danielle.gerard@novadip.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2024

First Posted

August 1, 2024

Study Start

August 22, 2024

Primary Completion (Estimated)

March 1, 2036

Study Completion (Estimated)

March 1, 2036

Last Updated

September 5, 2024

Record last verified: 2024-07

Locations

LU(1)