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InterStim Basic Evaluation Lead Post-Market Clinical Follow-up Study

NCT04016324 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-11-23

Study results available
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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

DEVICE

InterStim Basic Evaluation lead and foramen needle

Commercial devices within their intended use as described in approved Instructions for Use.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • BASIC Clinical Research Study Team · Medtronic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-28
Primary Completion
2020-10-06
Completion
2020-10-09
FDA Device
Yes

Countries

  • United States
  • Canada
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

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 NCT04016324 on ClinicalTrials.gov