Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT01056432
Status:
COMPLETED
Last Update Posted:
2014-03-31
First Post:
2010-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone UltraSonic Scanner (BUSS) Clinical Optimization Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-28', 'studyFirstSubmitDate': '2010-01-24', 'studyFirstSubmitQcDate': '2010-01-24', 'lastUpdatePostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osteoporosis, bone fracture risk, bone ultrasonometry'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.', 'detailedDescription': 'The specific aims of this clinical study are:\n\n1. To optimize the data collection technique and establish an examination procedure;\n2. To collect data necessary for assessing the performance of BUSS sensors;\n3. To evaluate the probe ergonomic design and participant tolerance to probe application;\n4. To assess the clinical suitability of the software interface in data collection;\n5. To adjust the BUSS diagnostic algorithms using dual-energy X-ray absorptiometry (DEXA) data as a "gold" standard in osteoporosis detection and characterization;\n6. To evaluate BUSS performance including ease of use and consistency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will consist of groups with no history of osteoporosis, established osteoporosis and may include documented history of fracture.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAny race or ethnical group DEXA examination scheduled within next two weeks or DEXA examination was completed within the last six months adn DEXA results are available\n\nExclusion Criteria:\n\nOpen wounds or rashes on the tibial testing area Active skin infection Recent tibia surgery Abnormal tibia Anatomy Current or previous tibial fracture Body Mass Index \\>34.9 Hyperparathyroidism or hypoparathyroidism within 5 years Osteitis deformans Renal osteodystrophy Osteomalacia Stroke with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs Drugs under research protocols Chronic use of over the counter antacids\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01056432', 'acronym': 'BUSS', 'briefTitle': 'Bone UltraSonic Scanner (BUSS) Clinical Optimization Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Artann Laboratories'}, 'officialTitle': 'Phase I Study of Portable Bone Ultrasonometer for Osteoporosis Assessment', 'orgStudyIdInfo': {'id': 'BUSS-02'}, 'secondaryIdInfos': [{'id': '2R44AG017400', 'link': 'https://reporter.nih.gov/quickSearch/2R44AG017400', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19115', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Health Smart Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Armen Sarvazyan, Ph.D., D.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Artann Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artann Laboratories', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}