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

September 23, 2025 updated by: Gelscom SAS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Recruiting
        • Hospital Pellegrin
        • Contact:
          • Mathieu de Sèze, Pr.
      • Saint-Dié, France
        • Terminated
        • Hospital St-Dié-des-Vosges
      • Saint-Pierre, France
        • Recruiting
        • Hospital SUD La Reunion
        • Contact:
          • Romain Kohlmann, Dr.
      • Saint-Priest-en-Jarez, France
        • Recruiting
        • Hospital St-Etienne
        • Contact:
          • Sylvain Grange, Dr.
      • Valence, France
        • Terminated
        • Hospital Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ethanol gel
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
Device: Ethanol gel
Intradiscal injection of ethanol gel
Other Names:
  • DISCOGEL®
Active Comparator: Steroid infiltration
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
Drug: Prednisolone acetate
Intradiscal infiltration of steroids
Other Names:
  • HYDROCORTANCYL 2,5 POUR CENT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Short-term efficacy profile
Time Frame: Month 3
Compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid: percentage of patients with a pain relief defined by a Low Back Pain (LBP) intensity<4 cm on a Local Verbal Rating Scale (0 = no pain to 10 = maximum imaginable pain)
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Long-term efficacy profile
Time Frame: Month 12
Compare the long-term efficacy profile of DISCOGEL® versus intradiscal steroid: Local Verbal Rating Scale: on back, bottom, thigh, leg, foot
Month 12
Long-term efficacy profile
Time Frame: Month 24
Compare the long-term efficacy profile of DISCOGEL® versus intradiscal steroid: Local Verbal Rating Scale: on back, bottom, thigh, leg, foot
Month 24
Short-term safety profile
Time Frame: Month 3
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Month 3
Long-term safety profile
Time Frame: Month 12
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Month 12
Long-term safety profile
Time Frame: Month 24
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Month 24
Questionnaire OSWESTRY
Time Frame: Month 24
Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale
Month 24
Questionnaire MacNab
Time Frame: Month 24
Subjective improvement 24 months after treatment: MacNab scale
Month 24
Radiography
Time Frame: Month 3
Describe radiologic evolution of the lesions: radiography of the herniated disc
Month 3
Radiography
Time Frame: Month 12
Describe radiologic evolution of the lesions: radiography of the herniated disc
Month 12
Radiography
Time Frame: Month 24
Describe radiologic evolution of the lesions: radiography of the herniated disc
Month 24
Magnetic Resonance Imaging
Time Frame: Month 3
Describe radiologic evolution of the lesions: MRI of the herniated disc
Month 3
Procedures costs
Time Frame: Day 0
Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery
Day 0
Procedures durations
Time Frame: Day 0
Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gelscom SAS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEISO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mathieu de Sèze, Dr, CHU Bordeaux Pellegrin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-A03259-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Discogenic Pain (Disorder)

Clinical Trials on Ethanol gel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings