[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519267":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Northwell Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Reparel Sleeve","EXPERIMENTAL","Device size(s): Small, medium, large, x-large Device model(s): Reparel Leg Sleeve (full length) Description of each component: Fabric garment constructed of 41% Polyester embedded with a proprietary non-metal semiconductive nano-sized material, 13% Polyester, 27% Nylon, and 19% Lycra-Spandex. The top cuff of the garment has silicone grips to keep the garment from sliding down.\n\n501k exempt: https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcdrh\u002Fcfdocs\u002FcfPCD\u002Fclassification.cfm?ID=FQL Company Name: Challenger Health, LLC (dba Reparel) FDA Registration Number: 3012651665 Device Listing Number: D269770 Product Classification: Class I Medical Device, 510(k) exempt Product Code: FQL, Stocking\u002FMedical Support",[13],"Device: Reparel Sleeve",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Sleeve","PLACEBO_COMPARATOR","Device size(s): Small, medium, large, x-large Device model(s): Generic Black Leg Sleeve Supplier: Jupin Group Co., Ltd. Description of each component: Fabric garment constructed of 80% polyester and 20% lycra",[19],"Device: Placebo Sleeve",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","For the purpose of this study, the Reparel Sleeve will be evaluated against a placebo sleeve of similar feel, texture, and look. The indication is that due to its technology, the Reparel sleeve will allow for the ability to reflect energy using a blend of semi-conductors grounded to nanoparticles interwoven between fibers of the sleeve. Thermal energy is then absorbed from the patient thus activating electrons on the nanoparticles and releasing photonic energy directed at tissues within the surrounding area7. This photostimulation is expected to alleviate pain and inflammation while promoting wound healing as well as tissue regeneration.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Nadia Baichoo, MA","CONTACT","516-640-1765","nbaichoo@orlincohen.com",{"name":36,"role":32,"phone":37,"phoneExt":25,"email":38},"Summer Koepplin","516-427-0340","skoepplin@orlincohen.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Orlin and Cohen Orthopedics","RECRUITING","Woodbury","New York","11797","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-74.10598,41.36454,{"lat":52,"lon":51},[55,56],{"name":31,"role":32,"phone":25,"phoneExt":25,"email":34},{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"James Paci, MD","PRINCIPAL_INVESTIGATOR",{"type":58,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"James Paci","Principal Investigator",[63],{"name":64,"class":65},"Reparel","INDUSTRY","100519267","novel-bioactive-sleeve-on-pain-and-proms-100519267",false,"NCT06041321","Novel Bioactive Sleeve on Pain and PROMs","The Effect of a Novel Bioactive Sleeve on Postoperative Pain and Patient Reported Outcome Scores After Arthroscopic Meniscectomy and Meniscus Repairs: A Randomized Placebo Controlled Study","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, over the age of 18, undergoing a meniscectomy or meniscus repair\n* In good general health as evidenced by medical history\n* Under 45th percentile BMI\n* Willing to adhere to the study intervention regimenregimen.\n* Kellgren-Lawrence grade 2 or less\n\nExclusion Criteria:\n\n* Febrile illness within 3 months\n* BMI over 40\n* Treatment with another investigational drug or other intervention within 6 months\n* Kellgren-Lawrence grade 3 or more or 4\n* History of autoimmune disease, circulatory disease, or vascular disorder","ALL","18 Years","89 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.",[84],"Meniscus Tear","2024-01-16",{"date":87,"type":88},"2024-01-18","ACTUAL",{"date":90,"type":88},"2023-12-06",{"date":92,"type":78},"2027-10",{"name":5,"class":6},1]