NCT03415828

Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Gelscom SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Discogenic Pain (Disorder)

Interventions

Type	Name	Description
DEVICE	Ethanol gel	Intradiscal injection of ethanol gel
DRUG	Prednisolone acetate	Intradiscal infiltration of steroids

Timeline

• Start date: 2018-05-29
• Primary completion: 2024-02-29
• Completion: 2027-05-29
• First posted: 2018-01-30
• Last updated: 2025-09-29

Locations

5 sites across 1 country: France