Ignite Creation Date:
2024-05-06 @ 3:42 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02357121
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2015-01-28
Brief Title:
Focal Laser Ablation of Prostate Tissue
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Focal Laser Ablation of Prostate Tissue A Pilot Feasibility Study Using MRIUS Image Fusion for Guidance
Status:
COMPLETED
Status Verified Date:
2020-04
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:
FLA
Brief Summary:
This is an open-label pilot feasibilityexploratory study to evaluate the safety of laser interstitial thermal therapy LITT using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation Subjects will be monitored for adverse events and health-related quality of life HRQOL questionnaires will be obtained Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes Biomarker PSA PCA3 and PHI kinetics will also be monitored
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JCCCID534 | OTHER | Jonsson Comprehensive Cancer Center | None |