At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Multi-Center, Randomized Controlled Trial for Skeletal Age Assessment AI Model
In Brief
A clinical study evaluating BoneAgeModel for Bone Age. Completed, enrolled 1,903 participants across 6 sites.
Detailed Summary
The purpose of this study is to understand the effects of using an Artificial Intelligence algorithm for skeletal age estimation as a computer-aided diagnosis (CADx) system. In this prospective real-time study, the investigators will send de-identified hand radiographs to the Artificial Intelligence algorithm and surface the output of this algorithm to the radiologist, who will incorporate this information with their normal workflows to make an estimation of the bone age. All radiologists involved in the study will be trained to recognize the surfaced prediction to be the output of the Artificial Intelligence algorithm. The radiologists' diagnosis will be final and considered independent to the output of the algorithm.
Study Details
Timeline
Interventions
BoneAgeModel is an Artificial Intelligence tool that takes in a hand radiograph and gender, and outputs the skeletal (bone) age. The intervention involves using this tool as a factor in the clinical decision making process of the participating radiologists. The radiologist's decision will be considered final.