Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-02 @ 11:05 AM
Study NCT ID:
NCT05371951
Status:
WITHDRAWN
Last Update Posted:
2023-03-23
First Post:
2022-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Erchonia Laser 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty in study subject recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2022-05-04', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Score on the International Index of Erectile Function - Erectile Function', 'timeFrame': '6 week', 'description': 'The International Index of Erectile Function - Erectile Function ( domain score is a patient questionnaire (six questions) used to measure various aspects of erectile performance and assess disease severity in efficacy trials concerning ED. The International Index of Erectile Function - Erectile Function has a minimum score of 0 and max of 30, higher scores mean a better outcome'}], 'secondaryOutcomes': [{'measure': 'Total Erection Hardness Score', 'timeFrame': '6 week', 'description': 'The Erection Hardness Score is a single-item scale that has demonstrated good psychometric properties for assessing erectile function in patients. The EHS has desirable measurement properties, including being highly responsive to treatment. This one-item PRO is robust and easy to use for evaluating erection hardness. The Total Erection Hardness Score has a minimum possible score of 0 and max of 4, higher scores mean a better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study is to see if applying low-level laser light can provide improvement in erectile dysfunction', 'detailedDescription': 'The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing improvement in erectile dysfunction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male between 40 and 80 years old\n* Known or suspected vasculogenic ED based on clinical history\n* In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment\n* Suffering from ED for at least 6 months\n* Testosterone level between 300 - 1000ng/dL within one month prior to enrollment\n* Hgb A1C less than or equal to 8% within one month prior to enrollment\n* Total IIEF-EF scores between 8-25\n* EHS score greater than or equal to\n\nExclusion Criteria:\n\n* ED due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment\n* Men with known neurogenic or psychogenic ED\n* Anatomic malformations of the penis including Peyronie's disease\n* Testosterone greater than 300ng/dL or 1000ng/dL\n* Hgb A1C greater than 8%\n* International Normalized Ratio greater than 2.5, and men on any blood thinners other than 81mg aspirin\n* Active testicular or prostate cancer"}, 'identificationModule': {'nctId': 'NCT05371951', 'briefTitle': 'Effect of Erchonia Laser on Erectile Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Erchonia Corporation'}, 'officialTitle': 'A Pilot Evaluation of the Effect of the Erchonia® HLS™ on Individuals With Erectile Dysfunction', 'orgStudyIdInfo': {'id': 'R-ED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erchonia HLS', 'description': '635 nanometers (nm) laser application', 'interventionNames': ['Device: Erchonia HLS']}], 'interventions': [{'name': 'Erchonia HLS', 'type': 'DEVICE', 'description': '84 procedure administrations with the Erchonia® HLS™ administered by the subject at home: twice daily procedure administrations for 6 weeks.', 'armGroupLabels': ['Erchonia HLS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Ranjodh S. Gill, MD, FACP', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erchonia Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}