At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Navina Smart (device), Standard Bowel Care (other)
- How long the study runs
- Study runs about 50 months (dates as stated)
- About the drug or intervention
- Navina Smart — device: CE-marked NavinaTM Smart including Navina Smart App. · Standard Bowel Care — other: Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 92
- Started
- 2020-12-01
- Last checked
- 2024-07
Plain English Summary
What is this study?
- • Testing a new treatment for neurogenic bowel (disorder)
- • NA - 92 participants
- • A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with neurogenic bowel (disorder)
Where?
- • London - University College London Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis and confirmed Neurogenic Bowel Dysfunction. The study is expected to last for a total of 8 weeks per subject with two scheduled site visits.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓For inclusion in the study, subjects must fulfil all of the following criteria:
- ✓Provision of agreement to take part.
- ✓Female or male aged 18 years or above.
- ✓Established diagnosis of MS according to McDonald criteria.
- ✓Patients with bowel symptoms post-dating and related to a diagnosis of MS.
Who cannot take part
- ✗Any of the following is regarded as a criterion for exclusion from the study:
- ✗Untreated rectal impaction.
- ✗Other significant neurological diseases (defined as all neurological diseases except for minor functional...
- ✗Opioid consumption ≤24 hours prior enrolment.
- ✗Previous colorectal surgery (including haemorrhoidectomy and fistulotomy), sphincter injury, perianal sepsis, rectal...
See the full criteria
Where Is This Study? (1 UK site)
University College London Hospital
London, United Kingdom
How to Get in Touch
Wellspect HealthCare
Sponsor contactCONTACT
