Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-03-14 @ 6:43 PM
Study NCT ID:
NCT04506866
Status:
TERMINATED
Last Update Posted:
2024-12-27
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Sponsor:
MedtronicNeuro
Organization:
Study Overview
Official Title:
Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the extension of the clinical study duration and to avoid further delaying the reporting of results.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELITE
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: