Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-04 @ 1:34 PM
Study NCT ID:
NCT02507427
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Safety and Efficacy of Pelvic Autonomic Nerve Monitoring and Mapping During Robot Assisted Laparoscopic Radical Prostatectomy for Preservation of Erectile Function
Status:
COMPLETED
Status Verified Date:
2019-02
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:
To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.
Detailed Description:
Using NIM-Eclipse monitoring instrument (Medtronic), we will check action potential of cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in real time during robot assisted laparoscopic radical prostatectomy for preservation of erectile function. In this feasibility and protocol setting phase I/II study, we will evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using NIM-Eclipse monitoring instrument.
Study Oversight
Has Oversight DMC:
True
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?: