Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 1:24 PM
Study NCT ID:
NCT04905069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2021-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABRE
Brief Summary:
To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.
Detailed Description:
This study is designed to evaluate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in participants undergoing Stereotactic Body Radiotherapy (SBRT) for the treatment of prostate cancer.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: