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

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ClinicalTrials.gov Identifier: NCT06385249

Recruitment Status : Recruiting

First Posted : April 26, 2024

Last Update Posted : April 26, 2024

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Wellspect HealthCare

Tracking Information

First Submitted Date ^ICMJE

April 17, 2024

First Posted Date ^ICMJE

April 26, 2024

Last Update Posted Date

April 26, 2024

Actual Study Start Date ^ICMJE

April 3, 2024

Estimated Primary Completion Date

October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall patient satisfaction [ Time Frame: 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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

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

Condition ^ICMJE

Bowel Dysfunction

Intervention ^ICMJE

Device: Navina Mini

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

Other Name: Trans-anal irrigation (TAI)

Study Arms ^ICMJE

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.

Intervention: Device: Navina Mini

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 2024

Estimated Primary Completion Date

October 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

3 Years to 17 Years (Child)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Peter Wide, MD

+46 010-1031341

Peter.Wide@regionostergotland.se

Listed Location Countries ^ICMJE

Sweden

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT06385249

Other Study ID Numbers ^ICMJE

NAV-0012

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Current Responsible Party

Wellspect HealthCare

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Wellspect HealthCare

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter Wide

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

PRS Account

Wellspect HealthCare

Verification Date

April 2024

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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