CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Navina Smartdevice
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/NCT02709395
NCT02709395N/ACompleted
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Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

Wellspect HealthCare·interventional·Posted Mar 16, 2016·Updated Jan 26, 2023

In Brief

A clinical study evaluating Navina Smart for Neurogenic Bowel. Completed, enrolled 28 participants across 2 sites in 2 countries.

Detailed Summary

This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurogenic Bowel
CountriesSweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 16, 2016
Enrollment StartFeb 1, 2016
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.3 years ago

Interventions

Navina Smartdevice

Transanal irrigation at the same frequency as subject used before enrollment.