[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07206615":3,"trial-entities:NCT07206615":74,"trial-summary:NCT07206615":78},{"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":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":25,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":57,"locations":60,"central_contacts":70,"overall_officials":71,"references":72,"see_also_links":73},"NCT07206615","CLN-00082","Spot Ex PMCF 01 Study","Post Market Clinical Follow-Up Study - Chart Review of the Spot Ex Endoscopic Marker","ENROLLING_BY_INVITATION","2025-12","2025-09","2025-10-14","2025-10","Laborie Medical Technologies Inc.","INDUSTRY",false,"Post market clinical study that is a chart review of the Spot Ex Endoscopic Marker","This study is a medical chart review to confirm the safety and performance of the Spot Ex Endoscopic Marker in accordance with the approved labelling\u002Finstructions for use (IFU).",[19],"Presence of Spot Ex Endoscopic Marker",[21,22,23],"Spot Ex","Endoscopic Marker","Laborie","OBSERVATIONAL",null,[],{"count":28,"type":29},60,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"OTHER","Endoscopic marker","Study to confirm the safety and performance of the Laborie Spot Ex Endoscopic Marker in accordance with the approved labelling\u002Finstructions for use (IFU).",[36],"Spot Ex Endoscopic Marker",[38],{"measure":39,"description":40,"timeFrame":41},"Longevity","Visual confirmation at 36 months - Percent of subjects with visual confirmation of the presence of Spot Ex as visualized by a clinician or in colonoscopy imaging at 36 months.","From endoscopic marker placement date to 36 months post-tattoo date",[43],{"measure":44,"description":45,"timeFrame":41},"Safety Endpoint","Percent of treatment-related adverse events specified in the protocol.","ALL","18 Years",{"inclusion":49,"exclusion":51,"raw_text":56},[50],"Patients who had a marking in their GI tract with the Spot Ex Endoscopic marker for the purposes of clinical surveillance.",[52,53,54,55],"1\\. Patients who had the marked tissue resected less than 3 years after initial marking.","2\\. Inadequate medical documentation to ascertain visualization of the marking.","3\\. Inability to visualize or image the marking due to poor colonoscopy preparation.","4\\. Patients considered as Vulnerable Populations, as defined in CFR - Code of Federal Regulations Title 21","Inclusion Criteria:\n\n* Patients who had a marking in their GI tract with the Spot Ex Endoscopic marker for the purposes of clinical surveillance.\n\nExclusion Criteria:\n\n* 1\\. Patients who had the marked tissue resected less than 3 years after initial marking.\n* 2\\. Inadequate medical documentation to ascertain visualization of the marking.\n* 3\\. Inability to visualize or image the marking due to poor colonoscopy preparation.\n* 4\\. Patients considered as Vulnerable Populations, as defined in CFR - Code of Federal Regulations Title 21",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"IU Health University Hospital","Indianapolis","Indiana","46202","United States",{"lat":68,"lon":69},39.76838,-86.15804,[],[],[],[],{"nct_id":4,"conditions":75,"biomarkers":77},[76],"Digestive System Disorder",[],{"nct_id":4,"found":15,"summary":25,"prompt_version":25}]