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InterStim Micro Post Market Clinical Follow-up Study (ELITE)

NCT04506866 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2024-12-27

Study results available
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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

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

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Mylène Champs · Medtronic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2022-12-19
Completion
2023-12-08
FDA Device
Yes

Countries

  • United States
  • Canada
  • France
  • Netherlands
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506866 on ClinicalTrials.gov