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Kintsugi Voice Device Pivotal Study

NCT06809907 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-04-30

No results posted yet for this study

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

Conditions

  • Depression
  • Depression Moderate
  • Depression Severe
  • Depression Mild

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.

Sponsors & Collaborators

  • Kolby Walker, DO

    collaborator UNKNOWN

  • Sonar Strategies

    collaborator UNKNOWN

  • Brittany Kimble

    collaborator UNKNOWN

  • Kintsugi Mindful Wellness, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2025-10-31
Completion
2025-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06809907 on ClinicalTrials.gov