Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT02622269
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2015-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-driven Compression in Urography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014570', 'term': 'Urologic Diseases'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation dose measured as Dose-area product', 'timeFrame': 'Immediately', 'description': 'Radiation dose for the investigated exposures, measured as Dose-area product'}], 'secondaryOutcomes': [{'measure': 'Image quality measured with Visual Grading', 'timeFrame': 'Immediately', 'description': 'Image quality for the investigated images, measured with Visual Grading'}, {'measure': 'Patient experience (questionnaire)', 'timeFrame': 'Immediately after the procedure', 'description': 'A questionnaire will be analysed with qualitative content analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urography', 'Radiation dosage', 'image enhancement'], 'conditions': ['Urologic Diseases']}, 'descriptionModule': {'briefSummary': "Compression of the abdomen during urography with either a patient-regulated compression device or conventional compression.\n\nEvaluation of radiation dose, image quality and patients' experiences", 'detailedDescription': "Patients are subjected to radiation from radiographical studies. The nurse can reduce the radiation dose for the individual by using dose-reducing measures. One of these is compression. It is known that compression in urography reduces the radiation dose because the radiation has less tissue to transverse when it is compressed. By reducing patient radiation doses, the risk of harmful radiation effects is reduced. This study aims to study if a patient-regulated compression device can reduce the radiation dose as effectively as the conventional compression, regulated by the nurse.\n\nTwo compression devices are investigated in each patient, in randomized order.\n\nAims of the study:\n\n1. Evaluate if the radiation doses are comparable with a patient-regulated compression device and conventional compression.\n2. Evaluate image quality with the two devices.\n3. Describe patients' experiences from using the two devices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with a request for a urographic study\n\nExclusion Criteria:\n\n* Emergency studies,\n* cannot participate actively with compression,\n* contraindications to compression of the abdomen,\n* pregnancy,\n* inability to understand the language of the questionnaire'}, 'identificationModule': {'nctId': 'NCT02622269', 'briefTitle': 'Patient-driven Compression in Urography', 'organization': {'class': 'OTHER', 'fullName': 'Örebro University, Sweden'}, 'officialTitle': 'Patient-driven Compression in Urography', 'orgStudyIdInfo': {'id': '183781'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient-regulated compression', 'description': 'Patient-regulated compression device', 'interventionNames': ['Device: Patient-regulated compression device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard compression', 'description': 'Standard compression device', 'interventionNames': ['Device: Standard compression device']}], 'interventions': [{'name': 'Patient-regulated compression device', 'type': 'DEVICE', 'description': 'Compression of the abdomen with a patient-regulated compression device', 'armGroupLabels': ['Patient-regulated compression']}, {'name': 'Standard compression device', 'type': 'DEVICE', 'description': 'Compression of the abdomen with the standard compression device', 'armGroupLabels': ['Standard compression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Department of Radiology', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Håkan Geijer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Örebro University, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro University, Sweden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Håkan Geijer', 'investigatorAffiliation': 'Örebro University, Sweden'}}}}