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

Bowel Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06385249
• Other study ID #: NAV-0012
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Wellspect HealthCare
• Contact: Peter Wide, MD
• Phone: +46 010-1031341
• Email: Peter.Wide[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
Sweden	H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety outcome	Assessment of adverse events and device deficiencies	up to 6 weeks