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NCT06809907 · ClinicalTrials.gov record · last posted 2026-08-14

Kintsugi Voice Device Pivotal Study

StatusCompleted
PhaseNot specified
Started2025-03-27
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from the ClinicalTrials.gov record
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

Protocol amendment history 4 changes detected by DataLookout

2026-08-15
Trial completed
2026-08-15
Enrollment increased: 1000 → 1600 participants
2026-08-15
Primary completion pushed: 2025-10 → 2026-02-28
2026-08-15
Completion pushed: 2025-11 → 2026-02-28
Trial Details
NCT Number NCT06809907
Lead Sponsor Kintsugi Mindful Wellness, Inc.
Collaborators: Kolby Walker, DO, Sonar Strategies, Brittany Kimble
Conditions Depression, Depression Moderate, Depression Severe, Depression Mild
Enrollment 1,600 participants
Start Date 2025-03-27
Primary Completion 2026-02-28 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-14