[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03782038":3,"trial-entities:NCT03782038":97,"trial-summary:NCT03782038":102},{"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":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":74,"locations":77,"central_contacts":93,"overall_officials":94,"references":95,"see_also_links":96},"NCT03782038","AIS 700-00053","Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars","A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars","RECRUITING","2019-11-21","2018-12","2018-12-21","2018-09-13","Cytrellis Biosystems, Inc.","INDUSTRY",false,"A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.","The study subject population will consist to up to 30 subjects who meet the inclusion\u002Fexclusion criteria. All subjects will be monitored for a period of 6 months post last treatment.\n\nAn study results will be assessed on the following:\n\n* POSAS - Patient Observer Scar Assessment\n* ASAS - Acne Scar Severity Scale\n* Subject Satisfaction Scale",[19],"Scars",[21,22,23],"Acne Scars","Stretchmarks","Surgical Scars","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},30,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","MCD","Micro coring skin removal with automated coring device",[37],"Micro-coring of scars with MCD",[39,43],{"measure":40,"description":41,"timeFrame":42},"Assess level of aesthetic improvement using POSAS scale 6 months post last treatment","Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10.","6 months post last treatment",{"measure":44,"description":45,"timeFrame":42},"Assess level of aesthetic improvement using ASAS scale 6 months post last treatment","Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4",[47],{"measure":48,"description":49,"timeFrame":42},"Assess safety profile by recording all adverse events reported during study","Adverse events will be recorded throughout the study","ALL","18 Years",null,true,{"inclusion":55,"exclusion":60,"raw_text":73},[56,57,58,59],"18 years of age or older","Fitzpatrick scale I-VI.","Any type of scar except for keloid scars","Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.",[61,62,63,64,65,66,67,68,69,70,71,72],"Previous treatment of the scar tissue within last 6 months.","Silicone, fat, collagen or synthetic material in the treatment area.","History of keloid formation.","Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.","Active, chronic, or recurrent infection.","Compromised immune system (e.g. diabetes).","Hypersensitivity to analgesic agents.","Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.","Pregnant or breastfeeding.","Any issue that, at the discretion of the investigator, would contra-indicate the subject's participation.","Any medication that may cause bleeding such as anticoagulants.","Allergy to lidocaine and\u002For epinephrine","Inclusion Criteria:\n\n* 18 years of age or older\n* Fitzpatrick scale I-VI.\n* Any type of scar except for keloid scars\n* Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.\n\nExclusion Criteria:\n\n* Previous treatment of the scar tissue within last 6 months.\n* Silicone, fat, collagen or synthetic material in the treatment area.\n* History of keloid formation.\n* Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.\n* Active, chronic, or recurrent infection.\n* Compromised immune system (e.g. diabetes).\n* Hypersensitivity to analgesic agents.\n* Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.\n* Pregnant or breastfeeding.\n* Any issue that, at the discretion of the investigator, would contra-indicate the subject's participation.\n* Any medication that may cause bleeding such as anticoagulants.\n* Allergy to lidocaine and\u002For epinephrine",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":90},"Miami Dermatology & Laser Institute","Miami","Florida","33173","United States",[85],{"name":86,"role":87,"phone":88,"email":89},"Nicole Rieth","CONTACT","305-279-6060","nicoler@miamidermlaser.com",{"lat":91,"lon":92},25.77427,-80.19366,[],[],[],[],{"nct_id":4,"conditions":98,"biomarkers":101},[99,100,22,23],"Acne scar","Scar",[],{"nct_id":4,"found":53,"summary":103,"prompt_version":113},{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study planning to enroll up to 30 participants. It is not specified if it is randomized or blinded.","completed","Study of a Micro Coring Device for Scar Treatment","This study is testing a new device called MCD (Micro Coring Device) to see how well it improves scars. Researchers want to know if using this device can make scars look better. You might be able to join if you are 18 or older, have any type of scar (except keloid scars), and haven't had other scar treatments in the last six months. The study will measure success by how much scars improve aesthetically (how they look) using two scales, POSAS and ASAS, six months after the last treatment. Up to 30 people are planned to join this study, but its current status is unclear.","Participants will be followed for 6 months after their last treatment.",105,"All participants will be monitored for a period of 6 months after their last treatment.","Not stated in the trial record.",[34],"v2"]