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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-10', 'studyFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2015-07-22', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion rate of nerve monitoring and mapping during RALP', 'timeFrame': 'During the operation', 'description': 'Completion rate of planed surgery without significant intra-operative complication'}], 'secondaryOutcomes': [{'measure': 'Adverse event', 'timeFrame': '12 months', 'description': 'Rate of adverse events during and after procedures upto 12 months'}, {'measure': 'Quantification of erectile nerve preservation', 'timeFrame': 'During the operation', 'description': '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.'}, {'measure': 'Correlation between the quantification and subjective nerve preservation grade', 'timeFrame': 'During the operation', 'description': 'Mean value of the quantification by nerve preservation grade (Tewari et al, 2011) which was subjectively scored by the surgeon.'}, {'measure': 'Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function', 'timeFrame': '12 months', 'description': 'Recovery duration of erection measured by the International Index of Erectile Dysfunction(IIEF)-5 score according to the quantification of erectile nerve preservation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate cancer, robot, nerve mapping and monitoring'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologically proven localized prostate cancer (≤cT3a)\n* patients to undergo robot-assisted laparoscopic prostatectomy at our center\n\nExclusion Criteria:\n\n* prior hormone therapy\n* prior radiation treatment on prostate or pelvis\n* refused to participate'}, 'identificationModule': {'nctId': 'NCT02507427', 'briefTitle': 'Monitoring and Mapping of Erectile Nerve During RALP (MMEN Study)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Safety and Efficacy of Pelvic Autonomic Nerve Monitoring and Mapping During Robot Assisted Laparoscopic Radical Prostatectomy for Preservation of Erectile Function', 'orgStudyIdInfo': {'id': 'H-1504-070-664'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerve monitoring arm', 'description': 'They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy.', 'interventionNames': ['Device: NIM-Eclipse']}], 'interventions': [{'name': 'NIM-Eclipse', 'type': 'DEVICE', 'description': 'Using NIM-Eclipse, nerve monitoring and mapping are performed', 'armGroupLabels': ['Nerve monitoring arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chang Wook Jeong, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No part of IPD will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Seoul National University Hospital', 'investigatorFullName': 'Chang Wook Jeong', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}