[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100317682":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":104,"collaborators":106,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":44,"enrollmentInfo":119,"targetDuration":44,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":44,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Gelscom SAS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ethanol gel","EXPERIMENTAL","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",[13],"Device: Ethanol gel",{"label":15,"type":16,"description":17,"interventionNames":18},"Steroid infiltration","ACTIVE_COMPARATOR","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",[19],"Drug: Prednisolone acetate",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Intradiscal injection of ethanol gel",[9],[26],"DISCOGEL®",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Prednisolone acetate","Intradiscal infiltration of steroids",[15],[33],"HYDROCORTANCYL 2,5 POUR CENT",[35],{"name":36,"affiliation":37,"role":38},"Mathieu de Sèze, Dr","CHU Bordeaux Pellegrin","STUDY_CHAIR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Mathieu De Sèze, Dr","CONTACT","+335 56 79 55 16",null,"corinne.pallas@chu-bordeaux.fr",{"name":47,"role":42,"phone":44,"phoneExt":44,"email":48},"Camélia Bentaleb","camelia.bentaleb@ceiso.fr",[50,65,74,85,96],{"facility":51,"status":52,"city":53,"state":44,"zip":44,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hospital Pellegrin","RECRUITING","Bordeaux","France","FR",{"type":57,"coordinates":58},"Point",[59,60],-0.58046,44.84124,{"lat":60,"lon":59},[63],{"name":64,"role":42,"phone":44,"phoneExt":44,"email":44},"Mathieu de Sèze, Pr.",{"facility":66,"status":67,"city":68,"state":44,"zip":44,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":73,"contacts":44},"Hospital St-Dié-des-Vosges","TERMINATED","Saint-Dié",{"type":57,"coordinates":70},[71,72],6.94921,48.28429,{"lat":72,"lon":71},{"facility":75,"status":52,"city":76,"state":44,"zip":44,"country":54,"countryCode":55,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Hospital SUD La Reunion","Saint-Pierre",{"type":57,"coordinates":78},[79,80],5.40682,43.29282,{"lat":80,"lon":79},[83],{"name":84,"role":42,"phone":44,"phoneExt":44,"email":44},"Romain Kohlmann, Dr.",{"facility":86,"status":52,"city":87,"state":44,"zip":44,"country":54,"countryCode":55,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hospital St-Etienne","Saint-Priest-en-Jarez",{"type":57,"coordinates":89},[90,91],4.37678,45.4739,{"lat":91,"lon":90},[94],{"name":95,"role":42,"phone":44,"phoneExt":44,"email":44},"Sylvain Grange, Dr.",{"facility":97,"status":67,"city":98,"state":44,"zip":44,"country":54,"countryCode":55,"cosmosGeoPoint":99,"geoPoint":103,"contacts":44},"Hospital Valence","Valence",{"type":57,"coordinates":100},[101,102],4.90956,44.9256,{"lat":102,"lon":101},{"type":105,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[107],{"name":108,"class":6},"CEISO","100317682","ethanol-gel-versus-steroid-in-refractory-lumbar-discogenic-pain-100317682",false,"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","IDIS","Inclusion Criteria:\n\n* Patient 18 years of age or older;\n* 2-month refractory pain to conservative treatment, non-surgical patients;\n* Chronic discogenic pain (1 or 2 lumbar discs) with concordant MR imaging;\n* Symptomatic for at least 8 weeks despite appropriate medical treatment;\n* Patient who agrees to participate in the study and who signed the informed consent form;\n* Patient with social protection.\n\nExclusion Criteria:\n\n* Previous surgical treatment of the studied disc(s);\n* Patient with pure radicular pain;\n* Sick leave of more than 12 months secondary to the symptoms;\n* Patients who cannot read or write French;\n* History of cognitive-behavioral disorders that could interact with assessment by self-questionnaire;\n* Local or general infection, or suspicion of infection;\n* Severe coagulation disorders;\n* Other rheumatic inflammatory disease;\n* Undercurrent serious pathology with life expectancy \\\u003C 2 years;\n* Female of childbearing age that are known to be pregnant during inclusion visit or wishing to become pregnant before treatment;\n* Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection\n* Patient participating in another interventional clinical trial or testing an experimental drug within 30 days of inclusion in the study.","ALL","18 Years",{"count":120,"type":121},230,"ESTIMATED","INTERVENTIONAL",[124],"NA","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.\n\nA 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.\n\nAs 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\u002F42\u002FEEC and MEDDEV guide 2.12\u002F2, to assess the efficacy and the long-term safety of DISCOGEL®.\n\nThe 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.\n\nThis 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.",[127],"Lumbar Discogenic Pain (Disorder)","2025-09-23",{"date":130,"type":131},"2025-09-29","ACTUAL",{"date":133,"type":131},"2018-05-29",{"date":135,"type":121},"2027-05-29",{"name":5,"class":6},5]