Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain (IDIS)

Gelscom

Status: Enrolling

Conditions: Lumbar Discogenic Pain (Disorder)

Treatments: Drug: Prednisolone acetate; Device: Ethanol gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03415828

2017-A03259-44

Details and patient eligibility

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient 18 years of age or older;
• 2-month refractory pain to conservative treatment, non-surgical patients;
• Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;
• Symptomatic for at least 8 weeks despite appropriate medical treatment;
• Patient who agrees to participate in the study and who signed the informed consent form;
• Patient with social protection.

Exclusion criteria

• Previous surgical treatment of the studied disc(s);
• Patient with pure radicular pain;
• Sick leave of more than 12 months secondary to the symptoms;
• Patients who cannot read or write French;
• History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;
• Local or general infection, or suspicion of infection;
• Severe coagulation disorders;
• Other rheumatic inflammatory disease;
• Undercurrent serious pathology with life expectancy < 2 years;
• Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;
• Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection
• Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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230 participants in 2 patient groups

Ethanol gel

Experimental group

Description:

CE-marked medical device used according to its instructions for use: GELSCOM® Single injection in the selected disc(s) of 0.6 to 2.2 ml

Treatment:

Device: Ethanol gel

Steroid infiltration

Active Comparator group

Description:

Authorized drug used according to its summary product characteristics: HYDROCORTANCYL 2,5 POUR CENT Single injection in the selected disc(s) of 0.2 to 2.0 ml

Treatment:

Drug: Prednisolone acetate