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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06377280
Study type Interventional
Source Wellspect HealthCare
Contact Louis Banka Johnson
Phone +4640336557
Email louis_banka.johnson@med.lu.se
Status Recruiting
Phase N/A
Start date January 18, 2024
Completion date December 2024

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