Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)

NCT ID: NCT02507427

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-26

Study Completion Date

2018-03-19

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nerve monitoring arm

They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy.

Group Type EXPERIMENTAL

NIM-Eclipse

Intervention Type DEVICE

Using NIM-Eclipse, nerve monitoring and mapping are performed

Interventions

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NIM-Eclipse

Using NIM-Eclipse, nerve monitoring and mapping are performed

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* pathologically proven localized prostate cancer (≤cT3a)
* patients to undergo robot-assisted laparoscopic prostatectomy at our center

Exclusion Criteria

* prior hormone therapy
* prior radiation treatment on prostate or pelvis
* refused to participate
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Wook Jeong

Seoul National University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Wook Jeong, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-1504-070-664

Identifier Type: -

Identifier Source: org_study_id

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