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Ethanol Gel Versus Steroid in Refractory Lumbar Discogenic Pain

NCT03415828 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-09-29

No results posted yet for this study

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

DEVICE

Ethanol gel

Intradiscal injection of ethanol gel

DRUG

Prednisolone acetate

Intradiscal infiltration of steroids

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • Gelscom SAS

    lead INDUSTRY

Principal Investigators

  • Mathieu de Sèze, Dr · CHU Bordeaux Pellegrin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2024-02-29
Completion
2027-05-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03415828 on ClinicalTrials.gov