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

Launched by WELLSPECT HEALTHCARE · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called Navina Mini, which helps children and teenagers who have bowel problems, such as constipation or fecal incontinence. The goal is to see how well the device works, how satisfied patients are with it, and to ensure that it is safe for young users. This study is currently recruiting participants, and children aged 3 to 17 years who have struggled with these issues for more than three months may be eligible to join.

To participate, children must have a signed consent form, and they should have been diagnosed with specific bowel conditions that haven't improved with regular laxatives. However, there are some exclusions; for example, children who have had certain surgeries recently or those with specific medical conditions won't be able to take part. If eligible, participants can expect to use the Navina Mini device under the guidance of the researchers, and their experiences and any changes in their bowel function will be closely monitored throughout the trial.

Gender

ALL

Eligibility 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