[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100346639":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":108,"collaborators":20,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":20,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":20,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":65,"whyStopped":20,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"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,[22,36,53,63,81,91],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":20},"Laser and Skin Surgery Center of Northern California","ACTIVE_NOT_RECRUITING","Sacramento","California","95816","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-121.4944,38.58157,{"lat":34,"lon":33},{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":28,"countryCode":29,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"AboutSkin Research, LLC","NOT_YET_RECRUITING","Greenwood Village","Colorado","80111",{"type":31,"coordinates":43},[44,45],-104.95081,39.61721,{"lat":45,"lon":44},[48],{"name":49,"role":50,"phone":51,"phoneExt":20,"email":52},"Audrey Langhorst","CONTACT","303-756-7546","research@aboutskinderm.com",{"facility":54,"status":24,"city":55,"state":56,"zip":57,"country":28,"countryCode":29,"cosmosGeoPoint":58,"geoPoint":62,"contacts":20},"Miami Dermatology & Laser Institute","Miami","Florida","33173",{"type":31,"coordinates":59},[60,61],-80.19366,25.77427,{"lat":61,"lon":60},{"facility":64,"status":65,"city":66,"state":66,"zip":67,"country":28,"countryCode":29,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Laser and Skin Surgery of New York","RECRUITING","New York","10016",{"type":31,"coordinates":69},[70,71],-74.00597,40.71427,{"lat":71,"lon":70},[74,78],{"name":75,"role":50,"phone":76,"phoneExt":20,"email":77},"Jennifer Moreno","212-686-7306","research@laserskinsurgery.com",{"name":79,"role":80,"phone":20,"phoneExt":20,"email":20},"Roy Geronemus","PRINCIPAL_INVESTIGATOR",{"facility":82,"status":24,"city":83,"state":84,"zip":85,"country":28,"countryCode":29,"cosmosGeoPoint":86,"geoPoint":90,"contacts":20},"The Office of Brian Biesman, M.D.","Nashville","Tennessee","37203",{"type":31,"coordinates":87},[88,89],-86.78444,36.16589,{"lat":89,"lon":88},{"facility":92,"status":38,"city":93,"state":94,"zip":95,"country":28,"countryCode":29,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Dallas Plastic Surgery Institute","Dallas","Texas","75231",{"type":31,"coordinates":97},[98,99],-96.80667,32.78306,{"lat":99,"lon":98},[102,106],{"name":103,"role":50,"phone":104,"phoneExt":20,"email":105},"Casey Martin","214-823-1978","Casey.Martin@dpsi.org",{"name":107,"role":80,"phone":20,"phoneExt":20,"email":20},"Jay Burns",{"type":109,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100346639","study-to-evaluate-the-safety-and-efficacy-of-the-cytrellis-micro-coring-device-for-the-treatment-of-moderate-to-severe-facial-wrinkles-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":122,"type":123},35,"ESTIMATED","INTERVENTIONAL",[126],"NA","Study evaluating the efficacy of a micro coring device for the treatment of moderate to severe check wrinkles",[129],"Wrinkle",[131,132,133],"facial wrinkles","skin laxity","sagging skin","2019-01-02",{"date":136,"type":137},"2019-01-04","ACTUAL",{"date":139,"type":137},"2018-11-12",{"date":141,"type":123},"2019-08-21",{"name":5,"class":6},6]