Evaluation of Navina Smart, Version 1.0
Research type
Research Study
Full title
Evaluation of a Novel Electronic Transanal Irrigation System - Navina Smart
IRAS ID
193953
Contact name
Anna-Karin Sundin
Contact email
Sponsor organisation
Wellspect HealthCare, part of DENTSPLY IH AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
This post-marketing study in approximately 30 patients intends to collect user data on the novel electronic Navina Smart system in those with neurogenic bowel dysfunction who require transanal irrigation (TAI). Such patients are likely to have e.g. spinal cord injury, multiple sclerosis or spina bifida and to suffer from defecation disorders including faecal incontinence and constipation. The Navina Smart system consists of a water container, tubing, connectors, a rectal balloon catheter and a control unit. Health status and needs of TAI users will be determined. Patient satisfaction, perception and compliance with the Navina Smart System will be recorded on a Patient Reported Outcome questionnaire. The study plan requires patients to attend at Baseline and Follow-up, 4 weeks later, with two telephone contacts at weeks 1 and 2. Safety of the Navina Smart system will also be assessed by recording all adverse events observed by the study staff or spontaneously reported by patients.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0460
Date of REC Opinion
28 Jan 2016
REC opinion
Further Information Favourable Opinion