[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07631468":3,"trial-entities:NCT07631468":86,"trial-summary:NCT07631468":89},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":23,"healthy_volunteers":23,"eligibility_criteria":46,"std_ages":56,"locations":59,"central_contacts":74,"overall_officials":83,"references":84,"see_also_links":85},"NCT07631468","ENDO-SYK-2025-02_PROSPECT","PROspect Registry :Post Market Clinical Follow-up Study","A Retrospective, Multi-center, Post-market Registry Study of Surgical Procedures in Endoscopy, Breast, and Urology (PROspect)","NOT_YET_RECRUITING","2031-12-01","2026-06","2026-06-08","2026-06-01","Stryker Endoscopy","INDUSTRY",false,"Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)","The purpose of this study is to leverage standard of care data on clinical outcomes following surgical procedures as indicated for each device.\n\n* Performance Objective: To collect clinical outcomes and Patient Reported Outcome Measures (PROMs) data (as applicable) on subjects that have undergone surgical breast procedures utilizing one or more Stryker devices.\n* Safety Objective: To collect data on safety events on the use of Stryker devices and\u002For related procedures",[19],"Breast Surgery",[21],"Breast surgery","OBSERVATIONAL",null,[],{"count":26,"type":27},5000,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Standard of care treatment","Subject has undergone breast surgical procedures using one of the study devices and meets eligibility criteria",[34],"Breast Surgical Procedures",[36,40],{"measure":37,"description":38,"timeFrame":39},"Successful marker localization","(proportion of MOLLI markers that are detected intraoperatively)","From the start of surgery to completion of surgery for each participant (assessed intraoperatively, up to the duration of the surgical procedure, typically within the same day)",{"measure":41,"description":42,"timeFrame":39},"Marker retrieval success","(proportion of procedures in which the MOLLI marker is removed within the surgical specimen)",[],"ALL","18 Years",{"inclusion":47,"exclusion":50,"raw_text":55},[48,49],"Subject was ≥ 18 years of age at the time of the surgery","Patients who have undergone breast surgical procedures using MOLLI, SPY-PHI, and\u002For SPY AGENT GREEN",[51,52,53,54],"Subjects who are less than 1-month post-intervention","Concurrent participation in an interventional investigational clinical study at the time of initial surgery","Subjects whose surgery date was prior to January 2022.","Pregnant or lactating females at the time of initial surgery","Inclusion Criteria:\n\n* Subject was ≥ 18 years of age at the time of the surgery\n* Patients who have undergone breast surgical procedures using MOLLI, SPY-PHI, and\u002For SPY AGENT GREEN\n\nExclusion Criteria:\n\n* Subjects who are less than 1-month post-intervention\n* Concurrent participation in an interventional investigational clinical study at the time of initial surgery\n* Subjects whose surgery date was prior to January 2022.\n* Pregnant or lactating females at the time of initial surgery",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":71},"Tufts Medical Center","Boston","Massachusetts","02111","United States",[67],{"name":68,"role":69,"email":70},"Abhishek Chatterjee Principle Investigator","CONTACT","abhishek.chatterjee1@tuftsmedicine.org",{"lat":72,"lon":73},42.35843,-71.05977,[75,79],{"name":76,"role":69,"phone":77,"email":78},"Prajakta Sawwalakhe, MD","16692077970","prajakta.sawwalakhe@stryker.com",{"name":80,"role":69,"phone":81,"email":82},"Colleen Roden","9312672041","colleen.roden@stryker.com",[],[],[],{"nct_id":4,"conditions":87,"biomarkers":88},[19],[],{"nct_id":4,"found":15,"summary":23,"prompt_version":23}]