Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521710
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase I Clinical Trial Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy
Status:
RECRUITING
Status Verified Date:
2024-09
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:
NR-RALP
Brief Summary:
The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring NR Robotically assisted laparoscopic radical prostatectomy RALP During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique NR-RALP which incorporates a genitofemoral GFN nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure
Detailed Description:
Patients will have baseline evaluation with International Index of Erectile Function-5 IIEF-5 questionnaire and the Short Form McGill Pain Questionnaire SF-MPQ1 which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks 3- 6- 12- and 18-months Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care
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