Phase
Condition
N/ATreatment
DXA Imaging
EOSedge imaging
Clinical Study ID
Ages > 20 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Observational Arm: o Subjects at clinical sites, indicated for full-spine or whole-body radiography viaEOSedge 2E biplanar imaging (e.g., in the preoperative evaluation of spine and/orother orthopaedic conditions) as part of their routine medical care. Participantsmay already have completed their routine imagining, or may be scheduled to undergoit within 60 days of study enrollment.
Interventional Arm: o Volunteers at non-clinical sites, who meet the criteria to undergo non-diagnosticimaging, as part of a research study.
Male or female subjects who are at least 20 years of age at the time of imagingacquisition
Written informed consent obtained from the potential subject and ability for thesubject to comply with the requirements of the study
Exclusion
Exclusion Criteria:
Subjects who have been administered contrast agents or radionuclides within 7 daysprior to scheduled radiographic imaging (EOS and DXA)
Subjects who are pregnant or wanting to become pregnant during the timeframe ofstudy participation (due to risks associated with radiographic imaging)
Subjects with a BMI ≥ 35 kg/m2
Subjects known to have severe degenerative changes or fracture deformity in themeasurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; notethat unilateral femoral evaluation is acceptable), as defined by the Investigator'sdetermination of the likelihood of reasonably assessing bone mineral density ofthose areas
Subjects known to have implants, hardware, devices, or other foreign material in themeasurement area (i.e., lumbar spine L1-L4, bilateral femoral neck/trochanter; notethat unilateral femoral evaluation is acceptable)
Subjects unable to attain correct position and/or remain motionless for themeasurement (e.g., subjects unable to stand unassisted in the EOS unit, or to lieappropriately in the DXA scanner)
Subjects known to have extra or missing lumbar vertebrae (i.e., more or fewer than 5mobile lumbar segments)
Subjects participating in another clinical study which may compromise this study'sresults or compliance with this study's procedures
Subjects with presence of a condition or abnormality that in the opinion of theInvestigator would compromise the safety of the subject or the quality of the data
Study Design
Study Description
Connect with a study center
Honor Health
Phoenix, Arizona 85027
United StatesActive - Recruiting
ATEC Carlsbad
Carlsbad, California 92008
United StatesSite Not Available
ATEC Mephis
Memphis, Tennessee 38118
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
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