Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT01317693
Status:
UNKNOWN
Last Update Posted:
2012-12-19
First Post:
2011-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-12-18', 'studyFirstSubmitDate': '2011-03-08', 'studyFirstSubmitQcDate': '2011-03-16', 'lastUpdatePostDateStruct': {'date': '2012-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success', 'timeFrame': '13 weeks'}], 'secondaryOutcomes': [{'measure': 'Rigidity Score Questionaire- an increase by at least 1 point is considered success', 'timeFrame': '13 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LI-ESWT', 'Erectile Dysfunction', 'ED', 'Shock waves', 'Therapy'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ED of more than 6 months\n* At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days\n* Positive response to PDE-5 inhibitors\n* IIEF-5 domain score of 12-20 denoting mild to severe ED\n* Non-Neurological pathology\n* Stable heterosexual relationship for more than 3 months\n\nExclusion Criteria:\n\n* NPT - normal/flat\n* Prior prostatectomy surgery\n* Any cause of ED other than vascular related\n* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities\n* Clinically significant chronic hematological disease\n* Cardiovascular conditions that prevent sexual activity\n* History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.\n* Cancer within the past 5 years.\n* Anti-androgens, oral or injectable androgens\n* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories'}, 'identificationModule': {'nctId': 'NCT01317693', 'briefTitle': 'Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction', 'orgStudyIdInfo': {'id': '0571-10-RMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment LI-ESWT', 'description': 'Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.', 'interventionNames': ['Device: Low intensity shock waves']}], 'interventions': [{'name': 'Low intensity shock waves', 'type': 'DEVICE', 'otherNames': ['Omnispec model ED1000'], 'description': '1500 shocks, Energy Density - 0.09 mJ/mm2', 'armGroupLabels': ['Treatment LI-ESWT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ilan Gruenwald, MD', 'role': 'CONTACT', 'email': 'i_gruewald@rambam.health.gov.il', 'phone': '00972-4-8542882'}, {'name': 'Yoram Vardi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ilan Gruenwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Boaz Appel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yaron Ofer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suliman Nassar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Omar Massarwa, RN BA', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ezra Gerber, RN BA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Ilan Gruenwald, MD', 'role': 'CONTACT', 'email': 'i_gruenwald@rambam.health.gov.il', 'phone': '00972-4-8542882'}], 'overallOfficials': [{'name': 'Ilan Gruenwald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Yoram Vardi, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'i_gruenwald', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}