Clinical trial NCT06385249: An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bowel Dysfunction
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 27
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Overall patient satisfaction
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Incomplete bowel emptying
timeFrame: up to 6 weeks
measure: Episodes of fecal incontinence
timeFrame: up to 6 weeks
measure: Level of independence
timeFrame: up to 6 weeks
measure: Perception of handling of the device
timeFrame: up to 6 weeks
measure: Safety outcome
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
Study officials:
affiliation: H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
name: Peter Wide
role: PRINCIPAL_INVESTIGATOR
References: