Kintsugi Voice Device Pivotal Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorKintsugi Mindful Wellness, Inc.
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. Recruitment will occur for 1 year and participation will be for up to 2 weeks
Eligibility criteria
Qualifiers
None
Disqualifiers
None
Trial design
Treatments tested in this trial
- Kintsugi Voice Device
Treatment groups
No treatment groups listed
Locations
1Kintsugi (Decentralized, Virtual Study)94707, BerkeleyCalifornia, United States
Sponsors and collaborators
Kintsugi Mindful Wellness, Inc.
Lead sponsor
Kolby Walker, DO
Collaborator
Sonar Strategies
Collaborator
Brittany Kimble
Collaborator
Source ClinicalTrials.gov