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Completed No phase listed Observational Accepts healthy volunteers

Kintsugi Voice Device Pivotal Study

ClinicalTrials.gov ID: NCT06809907

Public ClinicalTrials.gov record NCT06809907. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 10:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Kintsugi Voice Device SCID-5 Pivotal Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT06809907
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
Kintsugi Mindful Wellness, Inc.
Industry
Enrollment
1,600 participants

Conditions and interventions

Eligibility (public fields only)

Age range
22 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 26, 2025
Primary completion
Feb 27, 2026
Completion
Feb 27, 2026
Last update posted
Aug 13, 2026

2025 – 2026

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Kintsugi (Decentralized, Virtual Study) Berkeley California 94707

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06809907, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06809907 live on ClinicalTrials.gov.

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