{"type":"trials","record":{"id":41726,"source_id":"clinicaltrials-gov","external_id":"NCT06347107","title":"Robotic Subretinal tPA Injection Study","brief_summary":"In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following: * The robotic stabilizer (prototype - FAMHP approval received) * 41G subretinal needle (CE marked - used within label) * Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes. As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Universitaire Ziekenhuizen KU Leuven","enrollment":20,"countries":["Belgium"],"start_date":"2024-06-21","completion_date":"2025-08-12","last_update_date":"2025-09-02","source_url":"https://clinicaltrials.gov/study/NCT06347107","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"RoTIS","age_range":"18 Years","comparator":null,"organization":"Universitaire Ziekenhuizen KU Leuven","interventions":["Robotic subretinal tPA injection"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Percentage of patients with succesful subretinal insertion of the robot-held 41G needle — During surgery, once vitrecto…","Percentage of patients with stable subretinal position of the needle for at least 3 minutes. — During surgery, immediat…","Device-related adverse events — Duration of surgery: +/- 90 minutes","Functional outcome — 2 months post-operative"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Subretinal Hemorrhage","Age-Related Macular Degeneration","Robotic subretinal tPA injection"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct06347107","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-06-21 to 2025-08-12","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.860Z","intervention":["Robotic subretinal tPA injection"],"participants":20,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Percentage of patients with succesful subretinal insertion of the robot-held 41G needle — During surgery, once vitrecto…","Percentage of patients with stable subretinal position of the needle for at least 3 minutes. — During surgery, immediat…","Device-related adverse events — Duration of surgery: +/- 90 minutes","Functional outcome — 2 months post-operative"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41726","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}