Ethanol gel
DeviceIntradiscal injection of ethanol gel
Other names: DISCOGEL®
NCT Number: NCT03415828
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hospital Pellegrin, Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intradiscal injection of ethanol gel
Other names: DISCOGEL®
Intradiscal infiltration of steroids
Other names: HYDROCORTANCYL 2,5 POUR CENT
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)
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
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
Time frame: Month 3
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Time frame: Month 12
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Time frame: Month 24
Analyze the short- and long-term safety profile of DISCOGEL®: rates of complications and adverse reactions
Time frame: Month 24
Describe the rate of subjects improved 24 months after treatment: OSWESTRY scale
Time frame: Month 24
Subjective improvement 24 months after treatment: MacNab scale
Time frame: Month 3
Describe radiologic evolution of the lesions: radiography of the herniated disc
Time frame: Month 12
Describe radiologic evolution of the lesions: radiography of the herniated disc
Time frame: Month 24
Describe radiologic evolution of the lesions: radiography of the herniated disc
Time frame: Month 3
Describe radiologic evolution of the lesions: MRI of the herniated disc
Time frame: Day 0
Compare the cost linked to the DISCOGEL® procedure and the cost linked to a steroid infiltration or surgery
Time frame: Day 0
Compare the duration of the treatment procedures between a DISCOGEL® injection and a steroid infiltration or surgery
Contact information is provided by the study sponsor or research team.
Camélia Bentaleb
CONTACT
Mathieu De Sèze, Dr
CONTACT
Gelscom SAS
Industry
Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study
Acronym: IDIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.