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Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis

NCT03100032 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-08-13

No results posted yet for this study

Summary

A prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion (L1 - S1).

Conditions

  • Spondylolisthesis

Interventions

BIOLOGICAL

NVD-001

At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with NVD-001.

PROCEDURE

Standard of Care

At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally cancellous bone (laminectomy)

Sponsors & Collaborators

  • Novadip Biosciences

    lead INDUSTRY

Principal Investigators

  • Denis Dufrane, MD, PhD · Novadip Biosciences

  • Christian Raftopoulos, MD, PhD · Saint-Luc University Hospital, Department of Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-01-31
Completion
2021-06-30

Countries

  • Belgium
  • Czechia
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100032 on ClinicalTrials.gov