NCT04115228

Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Nine Continents Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study objectives: To report feasibility data for safety and effectiveness of the study device. Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580. Intended use: The study device is intended for treatment of the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. Type of design: Single-arm longitudinal design. Study sites: Single site, in the United States. Study duration: One year total, comprising six months for enrolling and implanting 10 subjects, and 26 weeks for follow-up.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	Implantation and neuromodulation therapy	The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.

Timeline

• Start date: 2019-10-09
• Primary completion: 2021-01-31
• Completion: 2021-03-03
• First posted: 2019-10-03
• Last updated: 2022-04-12
• Results posted: 2022-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study