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NCT01538628 · ClinicalTrials.gov registry record · Phase 3
SpaceOAR System Pivotal Study
A Phase 3 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 222
- Enrollment target
NCT01538628: Completed Phase 3 study, sponsored by Boston Scientific Corporation.
NCT01538628 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 222 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01538628, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 222 participants
- Enrollment target
Study Summary
Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)
Primary Outcome
Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.
Interventions
- DEVICE SpaceOAR System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
What the finished NCT01538628 record still lists
NCT01538628 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 1 intervention - of which SpaceOAR System is the first listed.
NCT01538628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01538628 about?
NCT01538628 is a clinical study titled "SpaceOAR System Pivotal Study". Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)
What is the current status of trial NCT01538628?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 222 participants. The study started on 2012-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01538628?
The interventions under investigation include: SpaceOAR System (DEVICE).
Who is sponsoring clinical trial NCT01538628?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01538628's enrollment target sits among peer trials
222 1317th of 2000 higher than 683 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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