Trials / Terminated
TerminatedNCT04506866
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 148 (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 to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InterStim Micro | Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use |
Timeline
- Start date
- 2020-08-25
- Primary completion
- 2022-12-19
- Completion
- 2023-12-08
- First posted
- 2020-08-10
- Last updated
- 2024-12-27
- Results posted
- 2024-01-05
Locations
24 sites across 6 countries: United States, Canada, France, Netherlands, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04506866. Inclusion in this directory is not an endorsement.