SpaceIT Hydrogel System for Perirectal Spacing
← catalyst calendarNCT06451614 · readout in 11 d
Sponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
230estimated
Sites
26
Countries
Canada, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-30 | actual | When the study began enrolling |
| Primary completion | 2026-08-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2024-06-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Prostate Cancer
Interventions
- Device: SpaceIT Hydrogel System
- Device: Commercially available Boston Scientific Spacer
Primary outcomes
what the primary-completion date above is the date OFPrimary Safety Endpoint - Acute Grade 3 or greater adverse events.
measured 90 Days from hydrogel placement procedure
Primary Effectiveness Endpoint - 25% reduction in the volume of the rectum receiving 90% of the prescribed radiation dose
measured 10 days post procedure
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