Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:36 PM
Study NCT ID:
NCT07331961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-12
First Post:
2025-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Feasibility of Using Dornier Machine in Patients With Erectile Dysfunction, a Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-31', 'studyFirstSubmitQcDate': '2026-01-08', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'detection of complications from the use of ESWL machine', 'timeFrame': 'follow up will begin after the first session and then repeated weekly for 1 month', 'description': 'the patients will be evaluated after the procedure for 1 month to identify any side-effects as hematoma or difficult urination'}, {'measure': 'improvement in the international erectile function score', 'timeFrame': 'follow up will begin after day one and then repeated weekly for 1 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['erectile dysfunction', 'low intensity shock wave treatment', 'extracorporeal shock wave therapy'], 'conditions': ['Erectile Dysfunction (ED)']}, 'referencesModule': {'references': [{'pmid': '21855209', 'type': 'RESULT', 'citation': 'Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.'}, {'pmid': '40654049', 'type': 'RESULT', 'citation': 'Ergun O, Kim K, Kim MH, Hwang EC, Blair Y, Gudeloglu A, Parekattil S, Dahm P. Low-intensity shockwave therapy for erectile dysfunction. Cochrane Database Syst Rev. 2025 Jul 14;7(7):CD013166. doi: 10.1002/14651858.CD013166.pub3.'}, {'pmid': '20451317', 'type': 'RESULT', 'citation': 'Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.'}, {'pmid': '35830338', 'type': 'RESULT', 'citation': 'Kalyvianakis D, Mykoniatis I, Pyrgidis N, Kapoteli P, Zilotis F, Fournaraki A, Hatzichristou D. The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. J Urol. 2022 Aug;208(2):388-395. doi: 10.1097/JU.0000000000002684. Epub 2022 May 6.'}]}, 'descriptionModule': {'briefSummary': 'Extracorporeal Shockwave Therapy (ESWT) is a well-established modality for treating various urological and musculoskeletal conditions. Recently, its application has expanded to include vasculogenic erectile dysfunction (ED), primarily due to its ability to trigger neo-angiogenesis and significantly improve penile blood flow.', 'detailedDescription': 'Extracorporeal Shockwave Therapy (ESWT) is a well-established modality for treating various urological and musculoskeletal conditions. Recently, its application has expanded to include vasculogenic erectile dysfunction (ED), primarily due to its ability to trigger neo-angiogenesis and significantly improve penile blood flow. While the clinical efficacy of Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT) is increasingly recognized globally, it currently remains non-FDA approved for this specific indication. Furthermore, the accessibility of this treatment is often limited, as dedicated Li-ESWT machines are expensive and frequently unavailable in public healthcare settings.\n\nThis pilot study investigates the feasibility of adapting the Dornier Delta Lithotripter utilized for high-energy renal stone fragmentation for penile therapy. The central research question focuses on whether this high-energy platform can be safely and precisely calibrated to low-intensity levels to provide therapeutic benefits without inducing tissue damage and complications.\n\nOur clinical rationale is inspired by shifting paradigms in other medical fields, such as prostate cancer radiotherapy, which emphasize delivering a concentrated therapeutic dose in fewer sessions. Since early pilot studies most notably by Vardi et al experimented with standardized five-point techniques over multiple weeks, we seek to optimize this by evaluating the impact of focused energy delivery and modified patient positioning.This research aims to provide a cost-effective, accessible alternative for ED treatment using existing hospital infrastructure.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'males', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with erectile dysfunction (ED) confirmed by clinical assessment and penile duplex Doppler ultrasound\n\nExclusion Criteria:\n\n* 1-Coagulapathy. 2-Penile prosthesis. 3-Post Radical Cystectomy 4-Intellectual disability 5-Skeletal abnormalty'}, 'identificationModule': {'nctId': 'NCT07331961', 'acronym': 'DED-Pilot', 'briefTitle': 'The Feasibility of Using Dornier Machine in Patients With Erectile Dysfunction, a Pilot Study.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of the Feasibility and Clinical Efficacy of Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT) Using the Dornier System in Patients With Vasculogenic Erectile Dysfunction: A Pilot Study', 'orgStudyIdInfo': {'id': 'ESWT in erectile dysfunction'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients diagnosed with erectile dysfunctiom', 'description': 'they will receive shock wave therapy on their penis by using a machine that is not designed for this purpose.', 'interventionNames': ['Device: extracorporeal shock wave therpy']}], 'interventions': [{'name': 'extracorporeal shock wave therpy', 'type': 'DEVICE', 'description': 'we will use a Dornier lithotripsy delta 2 for treatment of patient with erectile dysfunction', 'armGroupLabels': ['patients diagnosed with erectile dysfunctiom']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdelrahman M Abdelkader, Master of Urology & Andrology', 'role': 'CONTACT', 'email': 'abdelrahmanmohamed.aa@gmail.com', 'phone': '+201068336396'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assistant', 'investigatorFullName': 'Abdelrahman Mohamed Abdelkader', 'investigatorAffiliation': 'Assiut University'}}}}