Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04115228
Study type	Interventional
Source	Nine Continents Medical, Inc.
Contact
Status	Completed
Phase	N/A
Start date	October 9, 2019
Completion date	March 3, 2021

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See also
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