Evaluation of Implantable Tibial Neuromodulation Pivotal Study (TITAN 2)
NCT05226286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2025-11-21
Summary
The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.
Conditions
Interventions
- DEVICE
-
Medtronic Implantable Tibial Neuromodulation (TNM) System
Stimulation of the tibial nerve using Medtronic's tibial neuromodulation device.
Sponsors & Collaborators
-
MedtronicNeuro
lead INDUSTRY
Principal Investigators
-
Mylene Champs · 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
- 2022-01-31
- Primary Completion
- 2023-10-10
- Completion
- 2025-05-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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