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An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents

Bowel Dysfunction Clinical Trial

Official title:
An Uncontrolled, Prospective, Multicenter, Post-market Clinical Investigation to Confirm the Performance and Safety of Navina Mini, a New CE-marked Low-volume Trans-anal Irrigation (TAI) Device in Children and Adolescents

Clinical Trial Summary

The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.

Clinical Trial Description

This is an uncontrolled, prospective, multicentre post-market clinical follow-up investigation that will enroll male and female children /adolescents with a need for low-volume transanal irrigation (TAI) as judged by the investigator or designee. A total of 27 subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use. Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four (4) to six (6) weeks. The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm device safety when used in children and adolescents. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06385249
Study type Interventional
Source Wellspect HealthCare
Contact Peter Wide, MD
Phone +46 010-1031341
Email Peter.Wide@regionostergotland.se
Status Recruiting
Phase N/A
Start date April 3, 2024
Completion date December 2024
View Details
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