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NCT05882318 · ClinicalTrials.gov registry record · NA
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
A NA study, sponsored by Valencia Technologies Corporation.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT05882318: Completed NA study, sponsored by Valencia Technologies Corporation.
NCT05882318 is a NA study that has completed, run by Valencia Technologies Corporation. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05882318, a NA study, has completed, sponsored by Valencia Technologies Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is: * The reduction in UUI episodes per day on a 3-day voiding diary in both groups after 3 months of therapy Participants will be implanted with the eCoin device and randomized to either a sensory or subsensory stimulation group and complete voiding diaries and patient reported-outcomes through 3 months of therapy. After 3 months, subjects will be unblinded and reprogramming will be offered. Subjects will be followed for an additional month to a total of 4 months.
Primary Outcome
The primary endpoint is to explore the effect of two different eCoin amplitude settings on the change of UUI episodes per day on a 3-day voiding diary. A negative number shows a reduction in UUI episodes per day which means symptoms have improved since baseline. A positive number shows an increase in UUI episodes per day which means symptoms have worsened since baseline.
Interventions
- DEVICE eCoin Peripheral Neurostimulator System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2024-05-14 |
| Phase | NA |
What the finished NCT05882318 record still lists
NCT05882318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which eCoin Peripheral Neurostimulator System is the first listed.
NCT05882318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05882318 about?
NCT05882318 is a clinical study titled "Effectiveness of eCoin at Sensory and Subsensory Amplitudes". The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI). The main question it aims to answer is: * The reduction in UUI episodes per day ...
What is the current status of trial NCT05882318?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2023-06-06. Estimated completion is 2024-05-14.
What interventions are being tested in trial NCT05882318?
The interventions under investigation include: eCoin Peripheral Neurostimulator System (DEVICE).
Who is sponsoring clinical trial NCT05882318?
This trial is sponsored by Valencia Technologies Corporation, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05882318's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 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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