NCT04873271

Evaluation of Implantable Tibial Neuromodulation (TITAN 1) Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with overactive bladder.

Detailed description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	Medtronic Implantable Tibial Neuromodulation (TNM) System	Tibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve.

Timeline

• Start date: 2021-05-11
• Primary completion: 2021-08-04
• Completion: 2022-07-08
• First posted: 2021-05-05
• Last updated: 2022-07-13

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study