Evaluation of a new device for bowel dysfunction in children and adolescents
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
This study is testing a new device called the Navina Mini to see if it helps children and teenagers with bowel problems feel better and be satisfied with its use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | Wellspect HealthCare Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Linköping) |
| Trial ID | NCT06385249 on ClinicalTrials.gov |
What this trial studies
This clinical investigation assesses the Navina Mini, a trans-anal irrigation device, in children and adolescents suffering from bowel dysfunction. The study is an uncontrolled, prospective, multicentre follow-up that will enroll 27 subjects from 2-3 sites in Sweden. Participants will undergo three visits over a period of four to six weeks to evaluate clinical benefits, patient satisfaction, and device safety. The study aims to gather comprehensive data on the effectiveness and usability of the device in this population.
Who should consider this trial
Good fit: Ideal candidates include children and adolescents aged 3 to 17 with specific bowel dysfunction conditions not adequately managed by oral laxatives.
Not a fit: Patients requiring high-volume transanal irrigation or those with confirmed pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for children and adolescents with bowel dysfunction, improving their quality of life.
How similar studies have performed: While this approach is relatively novel, similar studies on transanal irrigation devices have shown promising results in adult populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Linköping
- H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset — Linköping, Sweden (Recruiting)
Study contacts
- Principal investigator: Peter Wide — H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
- Study coordinator: Peter Wide, MD
- Email: Peter.Wide@regionostergotland.se
- Phone: +46 010-1031341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.