Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594887
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Rectal Spacers Use in Prostate Cancer Radiation Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer Prospective Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy PBT Up to 50 subjects will be enrolled in this study
Study visits will include screening spacer placement treatment planning end-of-treatment assessment and follow-up visits at 1 3 and 6 months
Study visits will include screening spacer placement treatment planning end-of-treatment assessment and follow-up visits at 1 3 and 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None