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NCT05198518 · ClinicalTrials.gov registry record · NA
Microcurrent Device (TIVIC Health)
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT05198518: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05198518 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05198518, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.
Primary Outcome
Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after th
Interventions
- DEVICE Sham Device
- DEVICE Microcurrent TENS device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-03-30 |
| Est. Completion | 2024-04-04 |
| Phase | NA |
What the finished NCT05198518 record still lists
NCT05198518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Device is the first listed.
NCT05198518 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05198518 about?
NCT05198518 is a clinical study titled "Microcurrent Device (TIVIC Health)". The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). ...
What is the current status of trial NCT05198518?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-03-30. Estimated completion is 2024-04-04.
What interventions are being tested in trial NCT05198518?
The interventions under investigation include: Sham Device (DEVICE), Microcurrent TENS device (DEVICE).
Who is sponsoring clinical trial NCT05198518?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05198518's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 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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