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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 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 222 participants.
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)
Interventions
- DEVICE SpaceOAR System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01538628
The ClinicalTrials.gov registry entry for NCT01538628 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SpaceOAR System is the first listed.
NCT01538628 reports 0 study locations.
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.
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