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New device helps kids with bowel problems – study shows promise

NCT ID NCT06385249

Symptom relief Sponsor: Wellspect HealthCare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new, smaller bowel irrigation device called Navina Mini in 27 children and teens aged 3 to 17 with bowel problems like severe constipation or leakage. The goal was to see if the device is safe, easy to use, and improves bowel emptying and satisfaction. Results showed most participants were satisfied with the device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

27 people

The number who actually took part.

Started

Apr 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anorectal malformation bowel dysfunction constipation disorder Hirschsprung disease intestinal disorder neurogenic bowel

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bowel dysfunction

Contacts and locations

Locations

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

    Linköping, Sweden

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