Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT04398420
Status:
TERMINATED
Last Update Posted:
2023-01-09
First Post:
2020-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transurethral Vapor Enucleation Resection of the Prostate (TVERP), Bipolar TURis and HoLEP
Sponsor:
Olympus Surgical Technologies Europe
Organization:
Study Overview
Official Title:
Safety and Efficacy of TVERP in BPH Patients With Prostate Size ˃30 and ≤80 ml: a Comparison Study Between TVERP With the Plasma Vaporisation Button, Bipolar TURis and HoLEP Treatments.
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low recruitment. FUP of enrolled patients will be performed until LPLV.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To verify the safety and efficacy of the use of the plasma vaporisation button in Transurethral Vapor Enucleation and Resection of the prostate (TVERP) for treatment of Benign prostatic hypertrophy (BPH) patients with prostate ˃30 and ≤80 ml compare to TURis or HoLEP surgery methods.
Detailed Description:
None
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?: