Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT04423458
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Advanced US Tools in Assessing Allograft Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-05', 'releaseDate': '2023-09-29'}], 'estimatedResultsFirstSubmitDate': '2023-09-29'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D012078', 'term': 'Renal Artery Obstruction'}, {'id': 'D005355', 'term': 'Fibrosis'}], '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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D021621', 'term': 'Imaging, Three-Dimensional'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak systolic velocity (cm/s).', 'timeFrame': '12 weeks', 'description': 'Pean of the blood flow velocities in the artery/ vein peak systolic velocity ≥200 cm/s velocity difference between pre- and post-stenotic segments of 2:1'}, {'measure': 'Peak systolic velocity ratio (PSVR).', 'timeFrame': '12 weeks', 'description': 'High velocity flow at the stenosis site divided by a reference velocity (normal before stenosis)'}, {'measure': 'Resistive Index (RI).', 'timeFrame': '12 weeks', 'description': 'An RI less than 0.7 to 0.8 is considered normal, more than that it is indicator of transplant dysfunction.'}], 'secondaryOutcomes': [{'measure': 'Volumetric stenosis.', 'timeFrame': '12 weeks', 'description': 'Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.'}, {'measure': '3D GSM.', 'timeFrame': '12 weeks', 'description': 'Plaque volume is calculated automatically with the aid of software with a package of 3D laptop.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D Ultrasound', 'US elastography', 'US MFI', 'Ultrasound', 'MRI', 'CT'], 'conditions': ['Renal Failure', 'Chronic Kidney Diseases', 'Failure,Kidney', 'Renal Artery Stenosis', 'Fibrosis', 'Complications']}, 'descriptionModule': {'briefSummary': 'This study evaluates the role of advanced US technology in assessing renal transplants as screening tools such as 3D Ultrasound, Ultrasound SWE, and MFI besides current ultrasound conventional metheds.', 'detailedDescription': 'This study will focus on monitoring renal after transplantation using all US advanced technology.\n\nAim one will concentrate on the 3D US in assessing artery stenosis (TRAS) compared to the gold standard.\n\nAim two focuses on will concentrate on Ultrasound elastography in assessing renal stiffness.\n\nAim three will compare US colour modes such as PD, CD and MFI to assess renal perfusion in three groups.\n\nDuration: 18 Months; participants will have a patient information sheet; once they are happy to participate, consent will be obtained.\n\nStudy data will be entered into a database encrypted and stored in the department. Only the study principal investigator (PI) will know the study database password.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients having /had kindey transplant', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Patients ≥ 18 years.\n* Tx patients.\n* Gender.\n\nEXCLUSION CRITERIA\n\n* Prisoners.\n* Patients \\< 18 years.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT04423458', 'briefTitle': 'Evaluation of Advanced US Tools in Assessing Allograft Complications', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'The Evaluation of Advanced Ultrasonography Applications in the Assessment of Transplanted Kidney Complications', 'orgStudyIdInfo': {'id': '848 -20HH6053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transplanted kidney', 'description': 'No intervention is required. Routine Doppler assessment + 3D scan + Shear wave elastography + MicrFlow Imaging will be immediately recorded afterwards', 'interventionNames': ['Device: 3D imaging']}], 'interventions': [{'name': '3D imaging', 'type': 'DEVICE', 'description': 'The study will focus on the accuracy of ultrasound technology in assessing renal transplants.\n\nThe entire assessment should not take more than 25 minutes.', 'armGroupLabels': ['Transplanted kidney']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Mohammed Aslam, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Academic Supervisor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-09-29', 'type': 'RELEASE'}, {'date': '2024-04-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}