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Clinical Trial Summary

To evaluate the safety and effectiveness of the SpaceITâ„¢ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.


Clinical Trial Description

HYDROSPACE study is a prospective, randomized, multicenter study to evaluate the safety and effectiveness of SpaceIT in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer. Subjects randomized to the investigational arm will receive SpaceIT Hydrogel System Subjects randomized to the control arm will receive a commercially marketed Boston Scientific perirectal hydrogel spacer, SpaceOAR System or SpaceOAR Vue Hydrogel ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06451614
Study type Interventional
Source Boston Scientific Corporation
Contact Reshma Rao
Phone 952-930-6000
Email reshma.rao@bsci.com
Status Not yet recruiting
Phase N/A
Start date October 1, 2024
Completion date December 31, 2026

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