NCT06377280

En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device.

An Un-controlled, Prospective, Multi-center, Post Market Clinical Follow-up Investigation to Confirm Performance and Safety of Navina Mini, a New CE-marked Low-volume Transanal Irrigation (TAI) Device.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Wellspect HealthCare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational 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 during a period of four weeks. Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.

Conditions

• Bowel Dysfunction

Interventions

Type	Name	Description
DEVICE	Navina Mini	CE-marked Navina Mini, released on the market May 2023

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2024-04-22
• Last updated: 2025-01-31

Locations

1 site across 1 country: Sweden