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New anal insert aims to stop leakage and improve lives

NCT ID NCT04657588

Symptom relief Sponsor: Maastricht University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new, liquid-filled anal insert (called Navina) to help people with faecal incontinence (accidental bowel leakage). The device is designed to be comfortable and adapt to the body to prevent leaks. Researchers compared it to usual care in 73 adults aged 16-90 to see if it improves quality of life and is cost-effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Navina anal insert (a liquid-filled, single-use rectal device)
What this could lead to
If successful, this device could offer a comfortable, effective option to manage faecal incontinence and improve daily life for people with this condition.
What could go wrong
This is a small, completed trial (73 participants) comparing the device to usual care. Results may not apply to everyone, and the device may not work for all types of faecal incontinence.

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

73 people

The number who actually took part.

Started

Jun 2021

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

16 to 90 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: For run in period * Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months) * Aged between 16-90 years For randomisation and treatment period * Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months) * Aged between 16-90 years * patients who experience at least 1 episode of accidental bowel leakage during the 2 week run-in period will be eligible for randomisation. Exclusion Criteria: * Insufficient cognitive skills to fill in patient-reported questionnaires, inability to present to hospital for screening visit and inclusion, neurological/psychiatric or physical inability to comply with the study protocol (including diary assessments) at the investigator's discretion, or insufficient command of the Dutch language. * Anatomic abnormalities: known communication between the anal and vaginal tracts, prior diagnosis of congenital anorectal malformations, previous rectal surgery, radiotherapy to a pelvic organ (uterus, prostate, rectum). * Prior diagnosis of inflammatory bowel disease. * Pregnancy or intention to become pregnant during the study period.

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Conditions

The condition(s) this trial relates to.

Encopresis

As listed by the trial registrant

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

Faecal incontinence

Contacts and locations

Locations

  • Maastricht University Medical Centre

    Maastricht, Limburg, 6229HX, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.