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NCT06809907 · ClinicalTrials.gov registry record
Kintsugi Voice Device Pivotal Study
A clinical trial of Depression and Depression Mild, sponsored by Kintsugi Mindful Wellness.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT06809907 is a study of Depression and Depression Mild that is actively recruiting participants, run by Kintsugi Mindful Wellness. The registered enrollment target is 1,000 participants, above the 785-participant average among 679 other Depression trials with a reported enrollment target (27% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06809907, a study of Depression and Depression Mild, is actively recruiting participants, sponsored by Kintsugi Mindful Wellness.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Kintsugi Voice Device
Study Locations (1)
California
- Kintsugi (Decentralized, Virtual Study) - Berkeley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2025-03-27 |
| Est. Completion | 2025-11 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06809907
The ClinicalTrials.gov registry entry for NCT06809907 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 785-participant average among 679 other Depression trials with a reported enrollment target (27% higher). The listed sponsor is Kintsugi Mindful Wellness, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Kintsugi Voice Device is the first listed.
NCT06809907 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06809907 about?
NCT06809907 is a clinical study titled "Kintsugi Voice Device Pivotal Study". 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 (SCI...
What is the current status of trial NCT06809907?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2025-03-27. Estimated completion is 2025-11.
What conditions does trial NCT06809907 study?
This clinical trial studies the following conditions: Depression, Depression Mild, Depression Moderate, Depression Severe.
What interventions are being tested in trial NCT06809907?
The interventions under investigation include: Kintsugi Voice Device (DEVICE).
Who is sponsoring clinical trial NCT06809907?
This trial is sponsored by Kintsugi Mindful Wellness, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06809907 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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