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SpaceOAR Clinical Studies

The recently published results of the SpaceOAR System randomized clinical trial demonstrated that the spacer was safe, that patients tolerated it well, and that the spacer significantly reduced rectum radiation injury. This reduced rectal radiation decreased reports of pain during radiation treatment, and 1 year after radiation treatment decreased the rectum complications by 71%.

In the year following radiation treatment, clinical trial patients that did not get SpaceOAR System were 3.5 times more likely to have rectal complications than those who did.

Rectal Pain
Rectal Toxicity

Odds for late rectal toxicity (15 months)

Clinical study results for SpaceOAR in men who were treated with radiation therapy for prostate cancer

  • Grade 1: Mild, transient
  • Grade 2: Moderate, requiring prescription medication
  • Grade 3: Additional procedure required for treatment

Reference: http://www.redjournal.org/article/S0360-3016(15)00430-7/pdf