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Kintsugi Voice Device Pivotal Study

Kintsugi Mindful Wellness, Inc. · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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depression
A prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-RV) for up to 1000 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks
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