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NCT04115228 · ClinicalTrials.gov registry record · NA
Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
A NA study of Overactive Bladder, sponsored by Nine Continents Medical.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04115228: Completed NA study of Overactive Bladder, sponsored by Nine Continents Medical.
NCT04115228 is a NA study of Overactive Bladder that has completed, run by Nine Continents Medical. The registered enrollment target is 10 participants, below the 207-participant average among 46 other Overactive Bladder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115228, a NA study of Overactive Bladder, has completed, sponsored by Nine Continents Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Study objectives: To report feasibility data for safety and effectiveness of the study device. Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580. Intended use: The study device is intended for treatment of the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. Type of design: Single-arm longitudinal design. Study sites: Single site, in the United States. Study duration: One year total, comprising six months for enrolling and implanting 10 subjects, and 26 weeks for follow-up.
Primary Outcome
For a participant analyzed, let x0 = average number of voids with leakage per 24 hours in first 72 hours of baseline diary, x1 = average number of voids with leakage per 24 hours in first 72 hours of 13-week diary, and x = percent change of urinary incontinence frequency from baseline to 13 weeks. Then x = 100 \* (x1 - x0) / x0. For example, a participant with an average of 4 voids with leakage per 24 hours in the first 72 hours of the baseline diary and 2 voids with leakage per 24 hours in the
Conditions Studied
Interventions
- DEVICE Implantation and neuromodulation therapy
Study Locations (1)
California
- Pacific Urology - San Ramon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2021-03-03 |
| Phase | NA |
What the finished NCT04115228 record still lists
NCT04115228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 207-participant average among 46 other Overactive Bladder trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which Implantation and neuromodulation therapy is the first listed.
NCT04115228 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04115228 about?
NCT04115228 is a clinical study titled "Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)". Study objectives: To report feasibility data for safety and effectiveness of the study device. Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580. Intended use: The study device is intended for treatment of the symptoms of ove...
What is the current status of trial NCT04115228?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-10-09. Estimated completion is 2021-03-03.
What conditions does trial NCT04115228 study?
This clinical trial studies the following conditions: Overactive Bladder.
What interventions are being tested in trial NCT04115228?
The interventions under investigation include: Implantation and neuromodulation therapy (DEVICE).
Who is sponsoring clinical trial NCT04115228?
This trial is sponsored by Nine Continents Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04115228 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04115228's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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