NCT06385249

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bowel Dysfunction

Interventions

Type	Name	Description
DEVICE	Navina Mini	Trans-anal irrigation (TAI) with a new CE-marked device, Navina Mini

Timeline

• Start date: 2024-04-03
• Primary completion: 2025-07-09
• Completion: 2025-07-09
• First posted: 2024-04-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: Sweden