RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
NCT05540626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276
Last updated 2025-05-07
Summary
The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period.
Conditions
Interventions
- DEVICE
-
Cala Trio
transcutaneous afferent patterned stimulation (TAPS)
Sponsors & Collaborators
-
CVS Healthspire Life Sciences Solutions
collaborator UNKNOWN -
Cala Health, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-08
- Primary Completion
- 2024-03-01
- Completion
- 2024-03-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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