Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451614
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-07
Brief Title:
SpaceIT Hydrogel System for Perirectal Spacing
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy EBRT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
HYDROSPACE
Brief Summary:
To evaluate the safety and effectiveness of the SpaceIT Hydrogel System in patients undergoing External Beam Radiotherapy EBRT for the treatment of prostate cancer
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None