Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-27 @ 9:11 PM
Study NCT ID:
NCT03038659
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2017-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Intima-media Thickness in Determining Arteriogenic Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2017-01-29', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'erectile dysfunction', 'timeFrame': 'six months', 'description': 'intima media thickness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Erectile dysfunction.', 'detailedDescription': 'The intima media thickness is increasingly used as a surrogate end point of vascular outcomes in clinical trials aimed at determining the success of interventions that lower risk factors for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral artery diseases, like disease of cavernosal artery). The investigators hypothesized that the IMT of cavernosal artery would add to the predictive value of vasculogenic erectile dysfunction risk and outcomes. This study seeks to evaluate these hypotheses with our experience, investigating the predictive accuracy of Cavernosal Doppler ultrasound findings for discriminating patients with vasculogenic erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Erectile dysfunction pateints', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Erectile dysfunction patients\n\nExclusion Criteria:\n\n* Penile trauma.'}, 'identificationModule': {'nctId': 'NCT03038659', 'briefTitle': 'Role of Intima-media Thickness in Determining Arteriogenic Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Adam International Hospital'}, 'officialTitle': 'Predictive Value of Measuring Intima-media Thickness of Cavernosal Artery in Diagnosis of Arteriogenic Erectile Dysfunction by Penile Duplex', 'orgStudyIdInfo': {'id': '2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Penile Duplex', 'description': 'Measuring intima media thickness', 'interventionNames': ['Device: Penile Duplex']}], 'interventions': [{'name': 'Penile Duplex', 'type': 'DEVICE', 'description': 'Measuring intima media thickness', 'armGroupLabels': ['Penile Duplex']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Erectile dysfunction'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adam International Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Ahmad Raef', 'investigatorFullName': 'Ahmad Raef Sadek', 'investigatorAffiliation': 'Adam International Hospital'}}}}