Kintsugi Voice Device Pivotal Study

Recruiting Observational Study
Depression Depression Moderate Depression Severe Depression Mild
Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
22 and older
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
Kintsugi Mindful Wellness, Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Age \>22 at the time of informed consent Self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exerci…
Contacts

Dr. Kolby Walker D.O.

(209) 662-5369

Kolby.Walker@vituity.com

CONTACT