Trials / Unknown
UnknownNCT04727385
Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease
First-in-human Pilot Study for the Safety Assessment of DXM Gel in Patients With Painful Lumbar Degenerative Disc Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Gelmetix · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
After being informed of the study and the potential risks, all patients matching the eligibility criteria and who have given their written consent will undergo a gel injection at day 0 after a period of screening of up to 14 days. Then, they will be followed-up for a variable period according to the cohort : * first cohort of 5 patients with only one disc to be treated will be followed during 48 weeks, * second cohort of 5 patients with 2 discs to be treated will be followed during 36 weeks, * third cohort of 10 patients with 1 or 2 discs to be treated will be followed during 24 weeks.
Conditions
- Degenerative Disc Disease
- Chronic Lower Back Pain
- Discogenic Pain
- Intervertebral Disc Degeneration
- Lumbar Disc Disease
- Lumbar Disc Degeneration
- Lumbar Disc Pain
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-09-15
- Primary completion
- 2021-10-01
- Completion
- 2021-10-01
- First posted
- 2021-01-27
- Last updated
- 2021-01-27
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04727385. Inclusion in this directory is not an endorsement.