MedTrace Logo

Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease

NCT04727385 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-01-27

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and the efficacy of an hydrogel (double cross-link microgel - DXM) injection into the intervertebral disc (IVD) space in patients with painful lumbar degenerative disc disease (DDD) over 24 to 48 weeks.

Conditions

  • Degenerative Disc Disease
  • Chronic Lower Back Pain
  • Discogenic Pain
  • Intervertebral Disc Degeneration
  • Lumbar Disc Disease
  • Lumbar Disc Degeneration
  • Lumbar Disc Pain

Interventions

DEVICE

Double Crosslink Microgel

DXM hydrogel is a pH responsive Double Cross-Linked microgel based on single internally cross-linked microspheres (comprising a methacrylic acid-methyl methacrylate-ethylene glycol dimethacrylate copolymer) The DXM gel is injected into the intervertebral disc (IVD) space via a standardised procedure similar to the routinely-performed Discography procedure. The disc approach described in the discography procedure has been reported to allow the injection of a solution in the centre of the disc. The injection of the gel takes about 2 min.

Sponsors & Collaborators

  • Excelya

    collaborator INDUSTRY

  • Gelmetix

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-15
Primary Completion
2021-10-31
Completion
2021-10-31

Countries

  • France

Study Locations

More Related Trials

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 NCT04727385 on ClinicalTrials.gov