Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04441320
Status:
UNKNOWN
Last Update Posted:
2022-06-16
First Post:
2020-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006869', 'term': 'Hydronephrosis'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2020-06-14', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patency rate', 'timeFrame': 'Up to 36 months', 'description': 'Number of patients evaluated with hydronephrosis'}, {'measure': 'Indwelling time', 'timeFrame': 'Up to 36 months', 'description': 'Number of months of the implant in the ureter'}, {'measure': 'Device related serious adverse events', 'timeFrame': 'Up to 36 months', 'description': 'Number of device related serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiation induced ureteral stricture', 'coated metal ureteral stent', 'safety', 'efficacy'], 'conditions': ['Ureteral Stricture', 'Hydronephrosis', 'Radiation Exposure']}, 'descriptionModule': {'briefSummary': 'A prospective, multicenter and controlled study to observe the efficacy and safety of coated metal ureteral stent in the treatment of radiation induced ureteral stricture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of ureteral stricture and hydronephrosis.\n2. Previous history of radiation therapy.\n3. Must be able to tolerate surgery.\n\nExclusion Criteria:\n\n1. Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter).\n2. Colon resection surgery patients.'}, 'identificationModule': {'nctId': 'NCT04441320', 'briefTitle': 'Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study', 'orgStudyIdInfo': {'id': 'URO-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMUS group', 'description': 'Coated metal ureteral stent is indwelled.', 'interventionNames': ['Device: Coated metal ureteral stent(CMUS)']}, {'type': 'OTHER', 'label': 'DJS group', 'description': 'Double-J stent is indwelled', 'interventionNames': ['Device: Double-J stent(DJS)']}], 'interventions': [{'name': 'Coated metal ureteral stent(CMUS)', 'type': 'DEVICE', 'description': 'Coated metal ureteral stent aims to treat the patients with refractory ureteral stricture, such as radiation induced ureteral stricture. In this study, CMUS is indwelled to observe the efficacy and safety in the treatment of radiation induced ureteral stricture compared with Double-J stent.', 'armGroupLabels': ['CMUS group']}, {'name': 'Double-J stent(DJS)', 'type': 'DEVICE', 'description': 'Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.', 'armGroupLabels': ['DJS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mingrui Wang, Doctor', 'role': 'CONTACT'}], 'facility': "Peiking university people's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Mingrui Wang', 'role': 'CONTACT', 'email': 'wangmingrui1995@pku.edu.cn', 'phone': '19801286883'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Huhao', 'investigatorAffiliation': "Peking University People's Hospital"}}}}