Trials / Completed
CompletedNCT04016324
InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study
InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- MedtronicNeuro · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InterStim Basic Evaluation lead and foramen needle | Commercial devices within their intended use as described in approved Instructions for Use. |
Timeline
- Start date
- 2019-11-28
- Primary completion
- 2020-10-06
- Completion
- 2020-10-09
- First posted
- 2019-07-11
- Last updated
- 2021-11-23
- Results posted
- 2021-11-23
Locations
15 sites across 4 countries: United States, Canada, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04016324. Inclusion in this directory is not an endorsement.