Key study findings:
- Primary efficacy endpoint for balloon-related reduction in rectal V70 was met and demonstrated consistently
- 97.9% of subjects achieved >25% reduction in rV70 (mean reduction 84.8%)
- Lower overall ≥ grade 1 rectal AEs through 6 months in balloon vs control (18% vs 23.1%)
- Balloon stability and lack of migration over entire course of radiotherapy demonstrated
- 98.5% rate of balloon degradation by 6 months
Pivotal Trial Comparison
Protecting Patients from Rectal Toxicity
Rectal toxicity is a highly prevalent complication during prostate cancer radiation. First generation rectal spacing solutions have measurably improved complication rates for patients with prostate cancer.