{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"HYDROSPACE","nct_id":"NCT06451614","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=hydrospace-nct06451614. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"HYDROSPACE","arms":[{"description":"Subjects randomized to the investigational arm will undergo a hydrogel procedure with the SpaceIT investigational device.","label":"SpaceIT Hydrogel System","type":"EXPERIMENTAL"},{"description":"Subjects randomized to the control arm will undergo a hydrogel procedure with the Boston Scientific commercially available SpaceOAR or SpaceOAR VUE device.","label":"Commercially available Boston Scientific Spacer","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2028-03-31","type":"ESTIMATED"},"conditions":["Prostate Cancer"],"enrollment":{"count":230,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"SpaceIT Hydrogel System","otherNames":[],"type":"DEVICE"},{"name":"Commercially available Boston Scientific Spacer","otherNames":[],"type":"DEVICE"}],"last_update":"2026-10-13","lead_sponsor":"Boston Scientific Corporation","official_title":"SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["NA"],"primary_completion_date":{"date":"2026-09-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Primary Safety Endpoint - Acute Grade 3 or greater adverse events.","timeFrame":"90 Days from hydrogel placement procedure"},{"measure":"Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose","timeFrame":"10 days post procedure"}],"references":[],"start_date":{"date":"2024-10-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"SpaceIT Hydrogel System for Perirectal Spacing","url":"https://clinicaltrials.gov/study/NCT06451614"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/hydrospace-nct06451614"}