CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Implantation and neuromodulation therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04115228
NCT04115228N/ACompleted
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Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

Nine Continents Medical, Inc.·interventional·Posted Oct 3, 2019·Updated Apr 12, 2022

In Brief

A clinical study evaluating Implantation and neuromodulation therapy for Overactive Bladder. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 3, 2019
Enrollment StartOct 9, 2019
Primary CompletionJan 31, 2021
Study CompletionMar 3, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.7 years ago

Interventions

Implantation and neuromodulation therapydevice

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.