Actively Recruiting
Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
Led by Gelscom SAS · Updated on 2025-09-29
230
Participants Needed
5
Research Sites
469 weeks
Total Duration
On this page
Sponsors
G
Gelscom SAS
Lead Sponsor
C
CEISO
Collaborating Sponsor
AI-Summary
What this Trial Is About
DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017). The device re-obtained its CE mark in 2017. A clinical evaluation was performed by bibliographic route in 2016. Clinical data on more than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period. As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this "Post-Market Clinical Follow-up" (PMCF) study in accordance with Directive 93/42/EEC and MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®. The study is comparative. The results will evaluate the performance and safety of the CE-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. It will include economic data. Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are authorized products used according to their intended use. This is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. The primary objective is to compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.
CONDITIONS
Official Title
Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years of age or older
- Pain lasting at least 2 months that does not improve with conservative treatment
- Chronic discogenic pain involving 1 or 2 lumbar discs confirmed by MRI
- Symptoms present for at least 8 weeks despite appropriate medical treatment
- Patient agrees to participate and has signed informed consent
- Patient has social protection
You will not qualify if you...
- Previous surgery on the affected disc(s)
- Pure radicular pain without discogenic pain
- Sick leave longer than 12 months due to symptoms
- Unable to read or write French
- History of cognitive-behavioral disorders affecting self-assessment
- Local or general infection or suspected infection
- Severe blood clotting disorders
- Other rheumatic inflammatory diseases
- Serious underlying conditions with life expectancy less than 2 years
- Pregnant women or women planning pregnancy before treatment
- Legal or administrative imprisonment, guardianship, or limited judicial protection
- Participation in another interventional clinical trial or experimental drug use within 30 days before inclusion
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Hospital Pellegrin
Bordeaux, France
Actively Recruiting
2
Hospital St-Dié-des-Vosges
Saint-Dié, France
Terminated
3
Hospital SUD La Reunion
Saint-Pierre, France
Actively Recruiting
4
Hospital St-Etienne
Saint-Priest-en-Jarez, France
Actively Recruiting
5
Hospital Valence
Valence, France
Terminated
Research Team
M
Mathieu De Sèze, Dr
CONTACT
C
Camélia Bentaleb
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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