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NCT04016324 · ClinicalTrials.gov registry record · NA
InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
A NA study, sponsored by MedtronicNeuro.
- Completed
- Registry status
- NA
- Development phase
- 110
- Enrollment target
NCT04016324: Completed NA study, sponsored by MedtronicNeuro.
NCT04016324 is a NA study that has completed, run by MedtronicNeuro. The registered enrollment target is 110 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04016324, a NA study, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
Study Summary
Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
Primary Outcome
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead placement using the InterStim basic evaluation lead. A motor or sensory response was determined at the time of lead placement. Amplitude was titrated up from 0 until a response was reported and/or observed. A sensory response was defined as the lowest amplitude where the subject first perceived sensation of the stimulation. A motor response was defined as the lowest amplitude of electrical stimul
Interventions
- DEVICE InterStim Basic Evaluation lead and foramen needle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-11-28 |
| Est. Completion | 2020-10-09 |
| Phase | NA |
What the finished NCT04016324 record still lists
NCT04016324 is an interventional study that assigns participants to a tested intervention. The registered 110 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 (92% lower).
The record links to 0 conditions, and to 1 intervention - of which InterStim Basic Evaluation lead and foramen needle is the first listed.
NCT04016324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04016324 about?
NCT04016324 is a clinical study titled "InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study". Post-market clinical follow-up for continued assessment of safety and performance of the InterStim basic evaluation lead and foramen needle(s) used during a therapy evaluation.
What is the current status of trial NCT04016324?
This trial is currently completed. It is a NA study. The enrollment target is 110 participants. The study started on 2019-11-28. Estimated completion is 2020-10-09.
What interventions are being tested in trial NCT04016324?
The interventions under investigation include: InterStim Basic Evaluation lead and foramen needle (DEVICE).
Who is sponsoring clinical trial NCT04016324?
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 NCT04016324's enrollment target sits among peer trials
110 816th of 2000 higher than 1,176 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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