Bowel DysfunctionNCT06385249
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
A study testing Navina Mini in people with Bowel Dysfunction, run by Wellspect HealthCare at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Bowel Dysfunction
- What is being tested?
- Navina Mini
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSweden
- Study dates
- 3 Apr 2024to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
Linköping
About this study
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
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.
Read the 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.
- Conditions
- Bowel Dysfunction
- Being tested
- Navina Mini
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navina MiniDevice
Also called Trans-anal irrigation (TAI)
Trans-anal irrigation (TAI) with a new CE-marked device, Navina Mini
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | 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. Receives: Device: Navina Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 6 weeks
Secondary outcomes (5)
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)
Measured: 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
Measured: 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
Measured: 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))
Measured: up to 6 weeks
Safety outcome
Assessment of adverse events and device deficiencies
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start3 Apr 2024
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Wide, Principal investigator, H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385249
- Sponsor's protocol ID
- NAV-0012
- Status last verified
- Sep 2025
- First submitted
- 17 Apr 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06385249
- Acronym / sponsor ID
- NAV-0012
- Conditions
- Bowel Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: Navina MiniThe 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- Symptom duration of > 3 months
- Subject and/or their legally designated representative can communicate in written and oral Swedish language
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navina MiniAlso: Trans-anal irrigation (TAI)Trans-anal irrigation (TAI) with a new CE-marked device, Navina Mini | Device | All subjects |
Primary outcome
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)
5 secondary outcomes
Incomplete bowel emptying
Time frame: up to 6 weeks
Episodes of fecal incontinence
Time frame: up to 6 weeks
Level of independence
Time frame: up to 6 weeks
Perception of handling of the device
Time frame: up to 6 weeks
Safety outcome
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Bowel Dysfunction
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wide principal investigator
H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navina Mini in people with Bowel Dysfunction, run by Wellspect HealthCare at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall patient satisfaction (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.