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

NCT06385249 | Completed

• 1 other identifier: NAV-0012
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• Overall patient satisfaction

  Overall patient satisfaction measured with a 5-graded assessment scale (Patient Reported Outcome (PRO) via Wellspect Questionnaire: 0 = Not at all satisfied, 1 = Not satisfied, 2 = Neither satisfied nor unsatisfied, 3=Satisfied, 4 = Very satisfied)

  up to 6 weeks

Secondary Outcomes (5)

• Incomplete bowel emptying

  up to 6 weeks

• Episodes of fecal incontinence

  up to 6 weeks

• Level of independence

  up to 6 weeks

• Perception of handling of the device

  up to 6 weeks

• Safety outcome

  up to 6 weeks

Study Arms (1)

All subjects

EXPERIMENTAL

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.

Device: Navina Mini

Interventions

Navina Mini DEVICE

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

Also known as: Trans-anal irrigation (TAI)

All subjects

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Signed informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (1)

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

Linköping, Sweden

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Peter Wide

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 26, 2024
• Study Start: April 3, 2024
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)