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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Trans-anal irrigation (TAI) with a new CE-marked device, Navina Mini
H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset
Linköping, Sweden
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)
Time frame: up to 6 weeks
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)
Time frame: 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
Time frame: 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
Time frame: 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))
Time frame: up to 6 weeks
Safety outcome
Assessment of adverse events and device deficiencies
Time frame: up to 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.