[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07568015":3,"trial-entities:NCT07568015":253,"trial-summary:NCT07568015":17},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":44,"secondary_outcomes":53,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":77,"locations":80,"central_contacts":245,"overall_officials":250,"references":251,"see_also_links":252},"NCT07568015","BTX-786-GTPS-02","ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain","ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain: A Multi-Center, Randomized, Controlled Trial (RENEU)","NOT_YET_RECRUITING","2029-11-01","2026-06","2026-06-29","2026-07-01","Brixton Biosciences, Inc.","INDUSTRY",false,"The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRx™ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid injection in adults aged 22-80 years. Participants will attend study visits and complete quality of life questionnaires. Participants will be followed for approximately 6-12 months after the study procedure.",null,[19,20,21],"Greater Trochanteric Pain Syndrome","Greater Trochanteric Pain Syndrome of Both Lower Limbs","Lateral Hip Pain",[23,24,25,26],"RENEU","ReneuRx™","ReneuRx","GTPS","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},100,"ESTIMATED",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","Triamcinolone acetate","A single dose of Triamcinolone 40mg injected directly into the hip joint.",[37],{"type":41,"name":25,"description":42,"armGroupLabels":43},"DEVICE","ReneuRx will be injected around the trochanteric branches of the femoral nerve.",[25],[45,49],{"measure":46,"description":47,"timeFrame":48},"Primary Effectiveness","The primary endpoint of this study is the proportion of subjects whose hip pain following activity (Timed Up and Go test) is reduced by ≥30% based on the NRS scale at 3 months post treatment","3-months post treatment",{"measure":50,"description":51,"timeFrame":52},"Primary Safety","Aggregate serious device-related adverse events through final follow-up visit","Through study completion, an average of 12-months",[54,58,61,63,66],{"measure":55,"description":56,"timeFrame":57},"Secondary Effectiveness","Numeric Rating Scales - The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his\u002Fher pain. With 0 being no pain and 10 being the most pain.","Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month",{"measure":55,"description":59,"timeFrame":60},"Patient Global Impressions Scale (PGIC) The Patient Global Impression of Change (PGIC) score is a self-reported measure used to assess a patient's perception of their overall improvement or worsening in health status following a specific treatment. It is often used in clinical trials and research studies to gauge the efficacy of interventions from the patient's perspective. The PGIC typically ranges from \"very much worse\" to \"very much improved\".","3 month and 6 month post-treatment",{"measure":55,"description":62,"timeFrame":57},"VISA-G (Victorian Institute of Sports Assessment-Gluteal Score) The Victorian Institute of Sport Assessment (VISA-) Gluteal (G) Questionnaire is a self-report clinical outcome measure used in patients with greater trochanteric pain syndrome (GTPS). It consists of eight questions that measure the domains of pain, function in daily living, and sports activities The VISA-G can be used to evaluate the functional impairment of a patient with a disorder of one or both lower extremities. It can be used to monitor the patient over time and to evaluate the effectiveness of an intervention.",{"measure":55,"description":64,"timeFrame":65},"Change in Timed-Up and Go (TUG) test scores","12 months post-treatment",{"measure":67,"description":68,"timeFrame":69},"Pain Relief","Onset of pain relief defined as time in days to pain reduced by 30% based on NRS score from baseline.","6-Month, 12-Month","ALL","22 Years","80 Years",{"inclusion":74,"exclusion":75,"raw_text":76},[],[],"Inclusion Criteria:\n\n1. Age 22 to 80, inclusive of any gender\n2. Baseline pain intensity of \\>5 of the Numeric Rating Scale (NRS) localized to the lateral aspect of the hip (with or without radiation to lateral thigh or buttock) despite current treatment\n3. Tenderness to palpation of the peritrochanteric space of the lateral hip in adults with Greater Trochanteric Pain Syndrome.\n4. At least 6 months of previous conservative treatments for subject's lateral hip pain (NSAID, acetaminophen, physical therapy, and\u002For cortisone injections) that are not currently providing relief\n5. Agree to see study investigator and study team for hip pain during the study period\n6. Willing\u002Fable to understand the informed consent form and provide written informed consent\n7. Able to complete outcome measures (including electronic patient reported outcome measures)\n\nExclusion Criteria:\n\n1. Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline\n2. History of cryoglobulinemia\n3. History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)\n4. History of cold urticaria\n5. History of Chilblain's (pernio) disease in the lower extremities\n6. History of Raynaud's disease\n7. Open and\u002For infected wounds or active tumor at or near the treatment site\n8. History of vascular surgery involving femoral vessels on theinjection side\n9. History of hip surgery of any kind to the index side within the past 6 months (e.g., arthroscopy, arthroplasty, etc.)\n10. History of trochanteric osteotomy, femoral osteotomy, or amputation\n11. Active bacterial or fungal infection that, at the discretion of the investigator, would preclude study participation\n12. Currently taking \\>60 MME\u002Fday\n13. History of systemic inflammatory conditions such as rheumatoid arthritis\n14. Bleeding disorders, unless appropriately stopped or reversed for the procedure at investigator's discretion\n15. Any neuropathic pain condition (e.g. - complex regional pain syndrome, lumbar radiculopathy) in the area of pain\n16. Presence of unstable psychiatric disease\n17. Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index hip(s) within the past 12 months\n18. Corticosteroid injection within the previous 3 months or orthobiologic therapy such as platelet rich plasma injections for the index hip(s) within the previous 6 months\n19. Known contraindication to use of a regional anesthetic block\n20. Pregnant, nursing, or intent of becoming pregnant during the study period\n21. Documented evidence of an overlapping pain pattern from another source that the Investigator believes to be indistinguishable from lateral hip pain\n22. Lumbar or sacroiliac fusion within the previous 6 months\n23. Any other condition (such as history of deep vein thrombosis, significant cardiovascular, renal failure\u002Fdialysis, hepatic or other systemic comorbidity\u002Fchronic pain condition including cancer) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data\n24. Body habitus\u002Fhip anatomy that would preclude the use of the product injection needle size\n25. Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment\n26. Pending litigation or disability status\n27. Unwilling to refrain from any scheduled surgeries that would impact the collection of study endpoint data during the duration of the study\n28. Subject is a prisoner",[78,79],"ADULT","OLDER_ADULT",[81,99,114,128,143,157,172,187,202,216,231],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":96},"Healthcare Outcomes Performance Company","Sun City","Arizona","85023","United States",[88,93],{"name":89,"role":90,"phone":91,"email":92},"Alison Klika","CONTACT","440-343-2001","alison.klika@hopco.com",{"name":94,"role":95},"John Kearney","PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},33.59754,-112.27182,{"facility":100,"city":101,"state":102,"zip":103,"country":86,"contacts":104,"geoPoint":111},"Emory Orthopedics and Spine Center","Johns Creek","Georgia","30097",[105,109],{"name":106,"role":90,"phone":107,"email":108},"Lavanya Veda","404-778-6608","lavanya.vedanarayanan@emory.edu",{"name":110,"role":95},"Casey Wagner",{"lat":112,"lon":113},34.02893,-84.19858,{"facility":115,"city":116,"state":117,"zip":118,"country":86,"contacts":119,"geoPoint":125},"Ochsner Health Center","New Orleans","Louisiana","70121",[120,123],{"name":121,"role":90,"email":122},"Latrell Mackey","latrell.mackey@ochsner.org",{"name":124,"role":95},"Maged Guirguis",{"lat":126,"lon":127},29.95465,-90.07507,{"facility":129,"city":130,"state":131,"zip":132,"country":86,"contacts":133,"geoPoint":140},"Skylight Health Research","Burlington","Massachusetts","01803",[134,138],{"name":135,"role":90,"phone":136,"email":137},"Alisha Garibaldi","781-328-6185","alisha.garibaldi@skylighthealthresearch.com",{"name":139,"role":95},"Tom McAlindon",{"lat":141,"lon":142},42.50482,-71.19561,{"facility":144,"city":145,"state":131,"zip":146,"country":86,"contacts":147,"geoPoint":154},"Mass General Brigham","Chestnut Hill","02467",[148,152],{"name":149,"role":90,"phone":150,"email":151},"Kahtryn Satko","617-732-9816","ksatko@bwh.harvard.edu",{"name":153,"role":95},"Robert Yong",{"lat":155,"lon":156},42.33065,-71.16616,{"facility":158,"city":159,"state":160,"zip":161,"country":86,"contacts":162,"geoPoint":169},"Virtua Health","Sewell","New Jersey","08080",[163,167],{"name":164,"role":90,"phone":165,"email":166},"Judith Conner","856-325-3264","jconner@virtua.org",{"name":168,"role":95},"Sean McMillan",{"lat":170,"lon":171},39.7665,-75.14434,{"facility":173,"city":174,"state":175,"zip":176,"country":86,"contacts":177,"geoPoint":184},"The Orthopaedic Center","Tulsa","Oklahoma","74137",[178,182],{"name":179,"role":90,"phone":180,"email":181},"Jessica Good","918-991-3602","jessicag@emedr.com",{"name":183,"role":95},"Yogesh Mittal",{"lat":185,"lon":186},36.15398,-95.99277,{"facility":188,"city":189,"state":190,"zip":191,"country":86,"contacts":192,"geoPoint":199},"Rothman Orthopaedics","King of Prussia","Pennsylvania","19406",[193,197],{"name":194,"role":90,"phone":195,"email":196},"Thema Nicholson","267-339-3615","Thema.Nicholson@rothmanortho.com",{"name":198,"role":95},"Steve Stache",{"lat":200,"lon":201},40.08927,-75.39602,{"facility":203,"city":204,"state":190,"zip":205,"country":86,"contacts":206,"geoPoint":213},"Pain Diagnostics & Interventional Care","Sewickley","15143",[207,211],{"name":208,"role":90,"phone":209,"email":210},"Alyssa Abrams","412-221-7640","research@davidprovenzanomd.com",{"name":212,"role":95},"David Provenzano",{"lat":214,"lon":215},40.53646,-80.1845,{"facility":217,"city":218,"state":219,"zip":220,"country":86,"contacts":221,"geoPoint":228},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",[222,226],{"name":223,"role":90,"phone":224,"email":225},"Jonathan Thompson","214-645-2260","jonathan.thompson@utsouthwestern.edu",{"name":227,"role":95},"Kelechi Okoroha",{"lat":229,"lon":230},32.78306,-96.80667,{"facility":232,"city":233,"state":219,"zip":234,"country":86,"contacts":235,"geoPoint":242},"All-American Orthopedic & Sports","Houston","77058",[236,240],{"name":237,"role":90,"phone":238,"email":239},"Austin Mercier","409-904-7991","austin.mercier@elevateclinical.com",{"name":241,"role":95},"Matthew Higgs",{"lat":243,"lon":244},29.76328,-95.36327,[246],{"name":247,"role":90,"phone":248,"email":249},"David Curd","314-480-2244","david.curd@brixtonbio.com",[],[],[],{"nct_id":4,"conditions":254,"biomarkers":257},[255,256],"Greater trochanteric pain syndrome","Trochanteric pain",[]]