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

Not Applicable

Recruiting

• Conditions: Bowel Dysfunction
• Interventions: Device: Navina Mini

• Registration Number: NCT06385249
• Lead Sponsor: Wellspect HealthCare

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.

Study Timeline

• Study Start: 2024-04-03
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Navina Mini	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.

Primary Outcome Measures

Name	Time	Method
Overall patient satisfaction	up to 6 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Safety outcome	up to 6 weeks	Assessment of adverse events and device deficiencies
Episodes of fecal incontinence	up to 6 weeks	Episodes of obstructed defecation outlet syndrome or episodes of fecal incontinence as documented in a diary on a daily basis
Perception of handling of the device	up to 6 weeks	Subjects' perception of handling of the device measured with a 5-graded assessment scale (PRO via Wellspect Questionnaire: Evaluation of Navina Mini (0 = Very difficult, 1 = Difficult, 2 = Neither difficult nor easy, 3= Easy, 4 = Very easy) or (0 = Strongly disagree, 1 = Agree, 2 = Neither agree nor disagree, 3 = Agree, 4 = Strongly agree))
Incomplete bowel emptying	up to 6 weeks	Subjects' perception of incomplete bowel emptying measured with a 4-graded assessment scale (PRO via Wellspect Questionnaire: 0 = Never, 1= Seldom, 2= Often, 3= Always)
Level of independence	up to 6 weeks	Patients population able to use the device themselves: need support during the whole procedure, need support in parts of the procedure, no support needed: Yes and No answers

Trial Locations

Locations (1)

H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset; 🇸🇪 Linköping, Sweden