A Phase 1/2 interventional study of NIM-Eclipse in Prostate Cancer, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Seoul National University Hospital · Phase 1/2, Interventional, and Treatment
To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 30 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy.
Device: NIM-Eclipse
Using NIM-Eclipse, nerve monitoring and mapping are performed
Completion rate of nerve monitoring and mapping during RALP
Completion rate of planed surgery without significant intra-operative complication
Time frame: During the operation
Adverse event
Rate of adverse events during and after procedures upto 12 months
Time frame: 12 months
Quantification of erectile nerve preservation
Changes in action potential after prostate removal from the baseline. Electrical stimulation will be given at each neurovascular bundle 3 times. Action potential will be measured at both corpus cavernosum.
Time frame: During the operation
Correlation between the quantification and subjective nerve preservation grade
Mean value of the quantification by nerve preservation grade (Tewari et al, 2011) which was subjectively scored by the surgeon.
Time frame: During the operation
Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function
Recovery duration of erection measured by the International Index of Erectile Dysfunction(IIEF)-5 score according to the quantification of erectile nerve preservation
Time frame: 12 months
Plan to share: No — No part of IPD will be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital