Illustration of SpaceOAR Hydrogel

SABRE Trial

SpaceOAR Vue™ Hydrogel

SABRE Trial


The SABRE Trial is the first global, clinical trial to evaluate the effectiveness of SpaceOAR Vue™ Hydrogel in prostate cancer patients receiving SBRT. SpaceOAR Vue, the next-generation radiopaque hydrogel, is designed to reduce the radiation dose to the rectum, thus minimizing the impact on patients' urinary, sexual and bowel functions.1
 
What does SABRE stand for?
Effectiveness of the SpaceOAR Vue System in subjects with prostate cancer being treated with Stereotactic Body Radiotherapy


Study objective

Demonstrate the effectiveness of SpaceOAR Vue Hydrogel in reducing late gastrointestinal (GI) toxicity in patients receiving SBRT for the treatment of prostate cancer.

Primary endpoint:

  • Proportion of patients experiencing late GI toxicity between 3 and 24 months after SBRT with or without placement of SpaceOAR Vue Hydrogel.

Secondary endpoint:

  • Proportion of patients experiencing a decrease in Expanded Prostate Cancer Index Composite (EPIC-26) bowel score greater than or equal to the minimal important difference (MID) in EPIC-26 bowel score from baseline to 24 months post-SBRT initiation.


Please visit clinicaltrials.gov or email Boston Scientific at SABREStudy@bsci.com to learn more.


Learn about the procedure

 

References
  1. Data on file with Boston Scientific.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France.
Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
SpaceOAR and SpaceOAR Vue Hydrogels are intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR and SpaceOAR Vue Hydrogels to reduce the radiation dose delivered to the anterior rectum.
Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.
As with any medical treatment, there are some risks involved with the use of SpaceOAR and SpaceOAR Vue Hydrogels. Potential complications associated with SpaceOAR and SpaceOAR Vue Hydrogels include, but are not limited to: pain associated with SpaceOAR and SpaceOAR Vue Hydrogels injection; pain or discomfort associated with SpaceOAR and SpaceOAR Vue Hydrogels; needle penetration of the bladder, prostate, rectal wall, rectum or urethra; injection of SpaceOAR and SpaceOAR Vue Hydrogels into the bladder, prostate, rectal wall, rectum or urethra; local inflammatory reactions; infection; injection of air, fluid or SpaceOAR and SpaceOAR Vue Hydrogels intravascularly; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; and rectal urgency. URO-989811-AA
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