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

NCT06385249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-09-26

No results posted yet for this study

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.

Conditions

  • Bowel Dysfunction

Interventions

DEVICE

Navina Mini

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

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Peter Wide · H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2025-07-09
Completion
2025-07-09

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06385249 on ClinicalTrials.gov