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NCT04758247 · ClinicalTrials.gov registry record · NA
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
A NA study, sponsored by Theranova, L.L.C..
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT04758247 is a NA study that has completed, run by Theranova, L.L.C.. The registered enrollment target is 12 participants.
The verdict
NCT04758247, a NA study, has completed, sponsored by Theranova, L.L.C..
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.
Interventions
- DEVICE TheraNova Neuromodulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2023-12-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04758247
The ClinicalTrials.gov registry entry for NCT04758247 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theranova, L.L.C., which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TheraNova Neuromodulation System is the first listed.
NCT04758247 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04758247 about?
NCT04758247 is a clinical study titled "Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms". To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder...
What is the current status of trial NCT04758247?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2021-10-28. Estimated completion is 2023-12-08.
What interventions are being tested in trial NCT04758247?
The interventions under investigation include: TheraNova Neuromodulation System (DEVICE).
Who is sponsoring clinical trial NCT04758247?
This trial is sponsored by Theranova, L.L.C., which has 11 total clinical trials registered on ClinicalTrials.gov.
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