Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599476
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy a 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 is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement
The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer
Study visits
Screening
Spacer placement
Treatment planning simulation
End of the radiation treatment
13and 6-months FU visits
The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer
Study visits
Screening
Spacer placement
Treatment planning simulation
End of the radiation treatment
13and 6-months FU visits
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