Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-24 @ 7:56 PM
Study NCT ID:
NCT01815593
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2013-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Enhanced External Counterpulsation on 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with erectile dysfunction are assigned to two groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-02', 'studyFirstSubmitDate': '2013-03-16', 'studyFirstSubmitQcDate': '2013-03-20', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erectile function evaluated by International Index of Erectile Function-5 questionnaire', 'timeFrame': '7 weeks'}], 'secondaryOutcomes': [{'measure': 'Endothelial function', 'timeFrame': '7 weeks', 'description': 'Flow-mediated dilation：In this method,brachial artery diameter is measured before and after an increase in shear stress that is induced by reactive hyperemia (FMD). Endothelial progenitor cells：Flow cytometry to detect changes in the number of endothelial progenitor cells'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erectile Dysfunction', 'Vascular Endothelium', 'Counterpulsation, External'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '17433083', 'type': 'BACKGROUND', 'citation': 'El-Sakka A, Morsy A, Fagih B. Enhanced external counterpulsation in patients with coronary artery disease-associated erectile dysfunction. Part I: effects of risk factors. J Sex Med. 2007 May;4(3):771-779. doi: 10.1111/j.1743-6109.2007.00458.x. Epub 2007 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) in patients with erectile dysfunction', 'detailedDescription': 'Patients with erectile dysfunction will be randomized into two groups: EECP intervention or not. Erectile function, hemodynamic parameters, vascular endothelial function will be measured and compared.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. men over 18 years old;\n2. provide signed informed consent;\n3. existence of erectile dysfunction\n4. agree not to use any other erectile dysfunction treatment at least one month;\n\nExclusion Criteria:\n\n1. history of long drug abuse;\n2. pelvic, spine, brain trauma or surgery;\n3. endocrine, liver, lung, kidney disease, malignancies, hematological disorders;\n4. abnormal urogenital status, such as small testicle (\\<2cm), penile plaques;'}, 'identificationModule': {'nctId': 'NCT01815593', 'acronym': 'EECPED', 'briefTitle': 'The Value of Enhanced External Counterpulsation on Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'A Prospective, Randomized Study of Enhanced External Counterpulsation for Patients With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'EECPED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced External Counterpulsation', 'description': 'Men with erectile dysfunction receive Enhanced External Counterpulsation treatment', 'interventionNames': ['Device: Enhanced external counterpulsation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Men with erectile dysfunction without Enhanced External Counterpulsation treatment'}], 'interventions': [{'name': 'Enhanced external counterpulsation', 'type': 'DEVICE', 'otherNames': ['EECP'], 'description': 'Enhanced external counterpulsation therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. The systolic deflation/ Diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. The patients receive 35-36 hours EECP intervention, 1 -hour session every day over a 7-week period.', 'armGroupLabels': ['Enhanced External Counterpulsation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiwei Zhang, PhD', 'role': 'CONTACT', 'email': 'zhweiw2@mail.sysu.edu.cn', 'phone': '8620-87334871'}, {'name': 'Deng Chun Hua, M. D.', 'role': 'CONTACT', 'email': 'dch0313@163.com', 'phone': '0086-13501519349'}, {'name': 'Chen Shen Fu, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yadong Zhang, M. D.', 'role': 'CONTACT', 'email': 'zhyadong@mail.sysu.edu.cn', 'phone': '862087755766', 'phoneExt': '8373'}, {'name': 'Zi Wan, M. D.', 'role': 'CONTACT', 'email': 'zi_wan2012@163.com', 'phone': '862087755766', 'phoneExt': '8227'}], 'overallOfficials': [{'name': 'Yan Zhang, M. D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Chen Sheng Fu,MD', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}