[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06856707":3,"trial-entities:NCT06856707":77,"trial-summary:NCT06856707":82},{"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":21,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":45,"sex":46,"minimum_age":17,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":47,"std_ages":56,"locations":60,"central_contacts":70,"overall_officials":71,"references":75,"see_also_links":76},"NCT06856707","110-002103","MIRA Registry Study","MIRA Surgical System Registry Study (MIRA Registry)","ENROLLING_BY_INVITATION","2028-06","2025-05","2025-05-07","2025-04-30","Virtual Incision Corporation","INDUSTRY",false,"The purpose of the MIRA Surgical System Registry is to accumulate and evaluate real world evidence experience as part of post-market surveillance using the MIRA Surgical System.\n\nThe studies primary goals are to:\n\n* To evaluate the performance of the MIRA Surgical System\n* To evaluate the Device Safety profile",null,[19,20],"Colon Procedures","Bowel Resection",[],"OBSERVATIONAL",[],{"count":25,"type":26},100,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DEVICE","Use of the MIRA Surgical System during surgery","Use of the MIRA Surgical System to perform robotically assisted colorectal surgery.",[33],"Surgical",[35],"Robotically Assisted Surgery",[37,41],{"measure":38,"description":39,"timeFrame":40},"Performance of MIRA Surgical System","Successful completion of the surgical procedure using the MIRA Surgical System without conversion to open surgery (Yes\u002FNo).","From time of procedure through completion of the surgical procedure",{"measure":42,"description":43,"timeFrame":44},"Device Safety","Incidence of Device related adverse events and Unanticipated Device Effects","From time of surgery using the MIRA Surgical System through 30 days following surgical procedure",[],"ALL",{"inclusion":48,"exclusion":52,"raw_text":55},[49,50,51],"Patients undergoing surgery using the MIRA Surgical System","Subject is able to provide informed consent","Subject is available for post operative follow up visit through 30 days",[53,54],"Has or is participating in another clinical trial which may confound study results","In the opinion of the investigator, patient is not likely to complete post-operative care and\u002For return for standard follow-up.","Inclusion Criteria:\n\n* Patients undergoing surgery using the MIRA Surgical System\n* Subject is able to provide informed consent\n* Subject is available for post operative follow up visit through 30 days\n\nExclusion Criteria:\n\n* Has or is participating in another clinical trial which may confound study results\n* In the opinion of the investigator, patient is not likely to complete post-operative care and\u002For return for standard follow-up.",[57,58,59],"CHILD","ADULT","OLDER_ADULT",[61],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"Bryan Medical Center","Lincoln","Nebraska","68512","United States",{"lat":68,"lon":69},40.8,-96.66696,[],[72],{"name":73,"affiliation":13,"role":74},"Piet Hinoul, M.D.","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":78,"biomarkers":81},[79,80],"Intestine Resection","Procedure on colon",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]