Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564415
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
European Registry for Transperineal Laser Ablation of Prostate TPLA for Lower Urinary Tract Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
European Registry for Transperineal Laser Ablation of Prostate TPLA for Lower Urinary Tract Symptoms LUTS Due to Benign Prostatic Obstruction BPO
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:
The goal of this observational study is to assess mid- and long-term effectiveness of Transperineal Laser Ablation of Prostate TPLA for the treatment of lower urinary tract symptoms LUTS due to benign prostatic obstruction measured by need andor time until surgical retreatment
Data regarding patient-reported outcomes measures PROMs flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform
Secondary objectives of the study are
To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction
To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes in order to explore the optimal indications and possible limitations of TPLA for LUTS
Data regarding patient-reported outcomes measures PROMs flowmetry parameters and safety about consecutive patients undergoing TPLA will be collected in a dedicated platform
Secondary objectives of the study are
To assess functional and safety outcomes in patients treated with transperineal laser ablation for LUTS due to benign prostatic obstruction
To identify possible differences in characteristics of patients treated with transperineal laser ablation among the centers and possible relations between treatment application and outcomes in order to explore the optimal indications and possible limitations of TPLA for LUTS
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