Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04797039
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2021-03-11
Brief Title:
MRI-Guided Cryoablation for Focal Native Prostate Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
MRI-Guided Cryoablation for Focal Native Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The purpose of this research is to collect data about the MRI cryoablation procedure your doctors would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed
Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure
Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure
Detailed Description:
The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system The system has been approved by the United States Food and Drug Administration FDA for soft tissue ablation and has been utilized successfully at Mayo All procedures will be performed according to approved indications the investigators wish to monitor the technique and collect data at the participants follow-up visits
The study only collects data about the MRI-guided cryoablation procedure the participants doctors would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed The participants doctor will advise the participants when the participants should return for follow-up visits These visits will be according to the participants doctors standard of care usually return visits are at 3-6months 12 months 24 months 36 months 48 months and 60 months after the procedure although the participants doctor may ask that the participants return for more frequent visits
The study only collects data about the MRI-guided cryoablation procedure the participants doctors would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed The participants doctor will advise the participants when the participants should return for follow-up visits These visits will be according to the participants doctors standard of care usually return visits are at 3-6months 12 months 24 months 36 months 48 months and 60 months after the procedure although the participants doctor may ask that the participants return for more frequent visits
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?:
None
Is an FDA AA801 Violation?:
None