Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain
Status:
Recruiting
Trial end date:
2022-05-29
Target enrollment:
Participant gender:
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.