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ACTIVE NOT RECRUITING

Kintsugi Voice Device Pilot Study

NCT06374056 · View on ClinicalTrials.gov ↗

Study Summary

A prospective, single arm, non-randomized, pilot 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-CT) for up to 500 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.

Interventions

  • DEVICE Kintsugi Voice Device

Study Locations (1)

California

  • Kintsugi Mindful Wellness Inc. — Berkeley

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2024-03-22
Est. Completion 2025-07-22

Sponsor

Kintsugi Mindful Wellness

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06374056

The ClinicalTrials.gov registry entry for NCT06374056 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kintsugi Mindful Wellness, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06374056 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06374056 about?

NCT06374056 is a clinical study titled "Kintsugi Voice Device Pilot Study". A prospective, single arm, non-randomized, pilot 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-...

What is the current status of trial NCT06374056?

This trial is currently active not recruiting. The enrollment target is 500 participants. The study started on 2024-03-22. Estimated completion is 2025-07-22.

What conditions does trial NCT06374056 study?

This clinical trial studies the following conditions: Depression, Depression Mild, Depression Moderate, Depression Severe. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06374056?

The interventions under investigation include: Kintsugi Voice Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06374056?

This trial is sponsored by Kintsugi Mindful Wellness, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06374056 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial