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NCT05540626 · ClinicalTrials.gov registry record · NA
RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
A NA study, sponsored by Cala Health.
- Completed
- Registry status
- NA
- Development phase
- 276
- Enrollment target
NCT05540626: Completed NA study, sponsored by Cala Health.
NCT05540626 is a NA study that has completed, run by Cala Health. The registered enrollment target is 276 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05540626, a NA study, has completed, sponsored by Cala Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 276 participants
- Enrollment target
Study 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.
Primary Outcome
Difference in tremor power after stimulation with Cala Trio (treated arm) and baseline tremor power without stimulation (SOC arm) over the first month of the study. Prior to and immediately after each of the first 40 stimulation sessions and every 7th session thereafter, the Cala Trio will direct the patient to perform postural hold tremor tasks to measure tremor power pre and post stimulation. The SOC arm will perform a tremor measurement only, without any stimulation sessions, for 1 month.
Interventions
- DEVICE Cala Trio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2021-04-08 |
| Est. Completion | 2024-03-01 |
| Phase | NA |
What the finished NCT05540626 record still lists
NCT05540626 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Cala Trio is the first listed.
NCT05540626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05540626 about?
NCT05540626 is a clinical study titled "RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor". 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.
What is the current status of trial NCT05540626?
This trial is currently completed. It is a NA study. The enrollment target is 276 participants. The study started on 2021-04-08. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT05540626?
The interventions under investigation include: Cala Trio (DEVICE).
Who is sponsoring clinical trial NCT05540626?
This trial is sponsored by Cala Health, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05540626's enrollment target sits among peer trials
276 383rd of 2000 higher than 1,618 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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