Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

  • STATUS
    Recruiting
  • participants needed
    230
  • sponsor
    Gelscom SAS
Updated on 8 November 2020
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Summary

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.

Details
Treatment Ethanol gel, Prednisolone acetate
Clinical Study IdentifierNCT03415828
SponsorGelscom SAS
Last Modified on8 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Lumbar Discogenic Pain (Disorder)?
Patient 18 years of age or older
-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 with at least one previous epidural infiltration
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 Modic 1 aspect
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 or wishing to become pregnant during the study
Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study
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