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

NCT ID: NCT06385249

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-03
• Study Completion Date: 2025-07-09

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All subjects

The subjects are children and adolescents with anal incontinence or bowel outlet problems and deemed suitable for and in need of low-volume TAI as assessed by the investigator.

Group Type: EXPERIMENTAL

Navina Mini

Intervention Type: DEVICE

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

Interventions

Navina Mini

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

Intervention Type: DEVICE

Other Intervention Names

Trans-anal irrigation (TAI)

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Male and female children/adolescents between 3 and 17 years of age at the time of inclusion
• Diagnosis of at least one of the following:

• functional constipation not well treated with oral laxatives
• functional fecal incontinence, either retentive or non-retentive (FNRFI: Functional Non-Retentive Fecal Incontinence) not well treated with oral laxatives
• neurogenic bowel dysfunction due to spinal abnormalities and/or spinal cord injury or cerebral palsy
• patient with sequelae of anorectal malformations to Hirschsprung disease
• Fecal Incontinence (FI) due to iatrogenic injury including tumor surgery sequelae
• Symptom duration of > 3 months
• Subject and/or their legally designated representative can communicate in written and oral Swedish language

Exclusion Criteria

• Children/adolescents previously treated with, or currently in need of, high volume TAI, i.e., volume > 250 ml
• Confirmed pregnancy at the time of enrollment
• Participating in another clinical investigation interfering with this investigation
• Subjects with an active, symptomatic, inflammatory bowel disease, radiation proctitis, and or active perianal fistula disease
• Rectal bleeding of uncertain origin or active hemorrhoidal bleeding
• < 6 months after anal or colorectal surgery
• Ongoing anti-coagulant therapy (i.e., NOACS, heparin, warfarin)
• Ischemic colitis
• Active anal fissure
• Inability to use the product or anyone to assist in its usage (hand function assessment)
• Person not suitable for the investigation according to the investigator's judgment

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellspect HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Wide

Role: PRINCIPAL_INVESTIGATOR

H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset

Locations

H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset

Linköping, , Sweden

Countries

Sweden

Other Identifiers

NAV-0012

Identifier Type: -

Identifier Source: org_study_id