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
Sponsors and collaborators
Kintsugi Mindful Wellness, Inc.
Lead sponsor
Kolby Walker, DO
Collaborator
Sonar Strategies
Collaborator
Brittany Kimble
Collaborator
Source ClinicalTrials.gov