[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100346639":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":107,"collaborators":20,"id":109,"slug":20,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":20,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":20,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Cytrellis Biosystems, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Micro-exisional skin removal","EXPERIMENTAL","Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment.",[13],"Device: MCD",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","MCD","Micro coring skin removal with automated coring device",[9],null,[22,35,52,62,80,90],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":20},"Laser and Skin Surgery Center of Northern California","ACTIVE_NOT_RECRUITING","Sacramento","California","95816","United States",{"type":30,"coordinates":31},"Point",[32,33],-121.4944,38.58157,{"lat":33,"lon":32},{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":28,"cosmosGeoPoint":41,"geoPoint":45,"contacts":46},"AboutSkin Research, LLC","NOT_YET_RECRUITING","Greenwood Village","Colorado","80111",{"type":30,"coordinates":42},[43,44],-104.95081,39.61721,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":20,"email":51},"Audrey Langhorst","CONTACT","303-756-7546","research@aboutskinderm.com",{"facility":53,"status":24,"city":54,"state":55,"zip":56,"country":28,"cosmosGeoPoint":57,"geoPoint":61,"contacts":20},"Miami Dermatology & Laser Institute","Miami","Florida","33173",{"type":30,"coordinates":58},[59,60],-80.19366,25.77427,{"lat":60,"lon":59},{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":28,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Laser and Skin Surgery of New York","RECRUITING","New York","10016",{"type":30,"coordinates":68},[69,70],-74.00597,40.71427,{"lat":70,"lon":69},[73,77],{"name":74,"role":49,"phone":75,"phoneExt":20,"email":76},"Jennifer Moreno","212-686-7306","research@laserskinsurgery.com",{"name":78,"role":79,"phone":20,"phoneExt":20,"email":20},"Roy Geronemus","PRINCIPAL_INVESTIGATOR",{"facility":81,"status":24,"city":82,"state":83,"zip":84,"country":28,"cosmosGeoPoint":85,"geoPoint":89,"contacts":20},"The Office of Brian Biesman, M.D.","Nashville","Tennessee","37203",{"type":30,"coordinates":86},[87,88],-86.78444,36.16589,{"lat":88,"lon":87},{"facility":91,"status":37,"city":92,"state":93,"zip":94,"country":28,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Dallas Plastic Surgery Institute","Dallas","Texas","75231",{"type":30,"coordinates":96},[97,98],-96.80667,32.78306,{"lat":98,"lon":97},[101,105],{"name":102,"role":49,"phone":103,"phoneExt":20,"email":104},"Casey Martin","214-823-1978","Casey.Martin@dpsi.org",{"name":106,"role":79,"phone":20,"phoneExt":20,"email":20},"Jay Burns",{"type":108,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100346639",false,"NCT03793348","Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles","A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles","Inclusion Criteria:\n\n* Males and females 40-70 years of age\n* Fitzpatrick Skin Type I to IV as judged by the Investigator\n* Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as judged by the Investigator\n* Able to provide written informed consent, understand and willing to comply with all study related procedures and follow-up visits.\n\nExclusion Criteria:\n\n* Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules\u002Fnodules or active inflammatory lesions in the areas to be treated\n* History of keloid formation or hypertrophic scarring\n* History of trauma or surgery to the treatment areas in the past 6 months\n* Scar present in the areas to be treated\n* Silicone injections in the areas to be treated\n* Injection of dermal fillers, fat or botulinum toxin, as well as any minimally invasive\u002Finvasive medical device for skin treatment, in the study treatment areas, within the past 6 months (i.e., dermabrasion, laser, RF devices)\n* Active smokers (0.5 pack\u002Fday) or having quit within 3 months prior to treatment\n* Active, chronic, or recurrent infection\n* History of compromised immune system or currently being treated with immunosuppressive agents\n* History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or epinephrine\n* Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment\n* Treatment with aspirin or other blood thinning agents within 14 days prior to treatment\n* History or presence of any clinically significant bleeding disorder\n* Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to participate in the study\n* Treatment with an investigational device or agent within 30 days before treatment or during the study period",true,"ALL","40 Years","70 Years",{"count":120,"type":121},35,"ESTIMATED","INTERVENTIONAL",[124],"NA","Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles",[127],"Wrinkle",[129,130,131],"facial wrinkles","skin laxity","sagging skin","2019-01-02",{"date":134,"type":135},"2019-01-04","ACTUAL",{"date":137,"type":135},"2018-11-12",{"date":139,"type":121},"2019-08-21",{"name":5,"class":6},6]