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NCT04506866 · ClinicalTrials.gov registry record · NA
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
A NA study, sponsored by MedtronicNeuro.
- Terminated
- Registry status
- NA
- Development phase
- 148
- Enrollment target
NCT04506866: Clinical Trial NA study, sponsored by MedtronicNeuro.
NCT04506866 is a NA study that was terminated before completion, run by MedtronicNeuro. The registered enrollment target is 148 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04506866, a NA study, was terminated before completion, sponsored by MedtronicNeuro.
- TERMINATED
- Registry status
- NA
- Development phase
- 148 participants
- Enrollment target
Study Summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
Primary Outcome
The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL).8 Specifically, The OAB-q consists of an 8-item symptom bother scale and 25-item HRQL scale with 4 domains: coping (8 items), concern/worry (7 items), sleep (5 items) and social interaction (5 items). The score for each of OAB-q domain are summed and transformed to a score
Interventions
- DEVICE InterStim Micro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2023-12-08 |
| Phase | NA |
Why NCT04506866 stopped before completion
NCT04506866 is an interventional study that assigns participants to a tested intervention. The registered 148 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 (89% lower).
The record links to 0 conditions, and to 1 intervention - of which InterStim Micro is the first listed.
NCT04506866 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04506866 about?
NCT04506866 is a clinical study titled "InterStim Micro Post Market Clinical Follow-up Study (ELITE)". Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
What is the current status of trial NCT04506866?
This trial is currently terminated. It is a NA study. The enrollment target is 148 participants. The study started on 2020-08-25. Estimated completion is 2023-12-08.
What interventions are being tested in trial NCT04506866?
The interventions under investigation include: InterStim Micro (DEVICE).
Who is sponsoring clinical trial NCT04506866?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04506866's enrollment target sits among peer trials
148 702nd of 2000 higher than 1,298 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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