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

An Uncontrolled, Prospective, Multicenter, Post-market Clinical Investigation to Confirm the Performance and Safety of Navina Mini, a New CE-marked Low-volume Trans-anal Irrigation (TAI) Device in Children and Adolescents

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Dysfunction
• Intervention / Treatment: Device: Navina Mini

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 Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Wide, MD; Phone Number: +46 010-1031341; Email: Peter.Wide@regionostergotland.se

Study Locations

• Sweden
  • Linköping, Sweden
    • Recruiting
    • H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
    • Contact: Peter Wide; Phone Number: +46101031341; Email: Peter.Wide@regionostergotland.se
    • Contact: Jenny Axelsson; Phone Number: +46101032432; Email: jenny.axelsson@regionostergotland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Navina Mini; Trans-anal irrigation (TAI) with a new CE-marked device, Navina Mini; Other Names: Trans-anal irrigation (TAI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incomplete bowel emptying	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)	up to 6 weeks
Episodes of fecal incontinence	Episodes of obstructed defecation outlet syndrome or episodes of fecal incontinence as documented in a diary on a daily basis	up to 6 weeks
Level of independence	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	up to 6 weeks
Perception of handling of the device	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))	up to 6 weeks
Safety outcome	Assessment of adverse events and device deficiencies	up to 6 weeks

Collaborators and Investigators

• Sponsor: Wellspect HealthCare
• Investigators: Principal Investigator: Peter Wide, H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: NAV-0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No