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RECRUITING
NCT06809907

Kintsugi Voice Device Pivotal Study

Sponsor: Kintsugi Mindful Wellness, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: Kintsugi Voice Device SCID-5 Pivotal Study

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2025-03-27

Completion Date

2025-11

Last Updated

2025-04-30

Healthy Volunteers

Yes

Interventions

DEVICE

Kintsugi Voice Device

The Kintsugi Voice Device is intended to be used to screen for the presence of voice signals consistent with a current moderate to severe depressive episode in patients aged 22 and older. The device is intended to be used by care providers licensed to screen for depression and in settings where the screening for depression occurs. The device is neither to be used in lieu of a complete patient evaluation nor to supplant any of the clinician's standard assessments for the screening or diagnosis of depression. The Kintsugi Voice Device is comprised of a software API and machine learning model that utilizes recorded voice samples as inputs and outputs the detection of signals consistent with current moderate to severe depressive episode as outputs.

Locations (1)

Kintsugi (Decentralized, Virtual Study)

Berkeley, California, United States