[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507119":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":33,"centralContacts":38,"locations":43,"responsibleParty":71,"collaborators":32,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":32,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"ZetrOZ, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SAM Ultrasound Device and Diclofenac Patch","EXPERIMENTAL","Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 12 weeks combined with 2.5% diclofenac patch. The SAM Device emits continuous ultrasound at 3-megahertz (MHz) frequency and 0.132 watts\u002Fcm\\^2 intensity.",[13,14],"Device: Sustained Acoustic Device with 2.5% Diclofenac Patch","Drug: 2.5% Diclofenac Patches",[16,27],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Sustained Acoustic Device with 2.5% Diclofenac Patch","Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3-megahertz (MHz) frequency and 0.132 Watts\u002Fcm\\^2 with 2.5% Diclofenac patches.",[9],[22,23,24,25,26],"ZetrOZ Ultrasound Device","Wearable Ultrasound Device","Long Duration Ultrasound","LITUS Device Wearable","Long Duration Low-Intensity Device",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","2.5% Diclofenac Patches","Topical pain relief-gel worn during treatment via SAM patch.",[9],null,[34],{"name":35,"affiliation":36,"role":37},"George K. Lewis, Ph.D.","ZetrOZ Systems","PRINCIPAL_INVESTIGATOR",[39],{"name":35,"role":40,"phone":41,"phoneExt":32,"email":42},"CONTACT","8882029831","george@zetroz.com",[44,61],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"ZetrOZ Systems LLC","RECRUITING","Trumbull","Connecticut","06611","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-73.20067,41.24287,{"lat":56,"lon":55},[59],{"name":35,"role":40,"phone":60,"phoneExt":32,"email":42},"18882029831",{"facility":62,"status":46,"city":63,"state":64,"zip":65,"country":50,"countryCode":51,"cosmosGeoPoint":32,"geoPoint":32,"contacts":66},"National Sports Medicine Institute","Lansdowne","Virginia","20176",[67],{"name":68,"role":40,"phone":69,"phoneExt":32,"email":70},"Timothy Johnson, MD","7037295010","tjohnson@nationalsportsmed.com",{"type":72,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100507119","phase-1-sustained-acoustic-medicine-sam-for-symptomatic-treatment-of-pain-related-to-bone-fracture-100507119",false,"NCT05883241","Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture","Inclusion Criteria:\n\n* Have physician-diagnosed bone fracture\n* Are between 18-80 years of age\n* Report a pain score between 3-7 (range: 0-10) prior to enrolment\n* Report that pain from fracture negatively affects quality of life\n* Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study\n* Are deemed appropriate by their physician or by the study site physician to participate.\n* Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.\n* Not use or initiate opioid and\u002For non-opioid analgesic medications.\n* Be willing to discontinue any other interventional treatment modalities on the affected area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).\n\nExclusion Criteria:\n\n* Cannot successfully demonstrate the ability to put on and take off the device.\n* Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.\n* Participated in a clinical trial for an investigational drug and\u002For agent within 30 days prior to screening.\n* Is pregnant.\n* Is a prisoner.\n* Is non-ambulatory (unable to walk).\n* Has a pacemaker.\n* Has a malignancy in the treatment area.\n* Has an active infection, open sores, or wounds in the treatment area.\n* Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.\n* Has a known neuropathy (disease of the brain or spinal nerves).\n* Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).\n* Are currently taking steroids.",true,"ALL","18 Years","80 Years",{"count":84,"type":85},90,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period.\n\nThe primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain.\n\nSecondary objectives are to assess the ability of LITUS to improve patients return to work time.",[91,92],"Bone Fracture","Fresh Fracture",[94,95,96,97,98,99,100],"Low-Intensity Ultrasound","Drug Delivery","Sonophoresis","Transdermal Drug Delivery","Non-Steroidal Anti-Inflammatory Drugs","Sustained Acoustic Medication","Low-Intensity Continuous Ultrasound","2025-02-25",{"date":103,"type":104},"2025-02-28","ACTUAL",{"date":106,"type":104},"2023-06-01",{"date":108,"type":85},"2026-02-28",{"name":5,"class":6},2]