Clinical trial NCT02709395: Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
Official title: Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bowel
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2016-03-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed as an open, prospective, single arm, multicenter study in order to investigate patient satisfaction, perception and compliance for the novel Navina Smart, a transanal irrigation (TAI) system. Approximately 30 male and female subjects who are currently practicing TAI, will be followed during a 4-week period of use of Navina Smart. Observational data on satisfaction, perception, compliance, bowel regimen, TAI therapy and TAI frequency will be collected via patient reported outcome (PRO) questionnaires.


Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent
2. Males and females, aged 18 years and over
3. Practice TAI since at least 2 months and at least two times per week
4. Able to read and fill out a paper PRO questionnaire as judged by the principal investigator or a sub-investigator

Exclusion Criteria:

1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions
2. Untreated rectal impaction
3. Any radiotherapy to the pelvis
4. Any current treatment with anticoagulants (not including aspirin or clopidogrel)
5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/ or local topical treatment)
6. Any prior rectal or colonic surgery (not including anal procedures \>3 months ago, e.g. haemorrhoid excision)
7. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks
8. Overt or planned pregnancy
9. Ongoing symptomatic urinary tract infection as judged by the principal investigator or a sub-investigator
10. Diagnosed psychiatric illness, considered as unstable by the principal investigator or a sub-investigator
11. Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
12. Previous enrolment in the present study
13. Participation in another clinical study within the last 30 days that may interfere with the present study

Primary outcomes:
measure: Questionnaire Measuring Subjects' Satisfaction of Navina Smart
timeFrame: 4 weeks
measure: Questionnaire Measuring Subjects' Perception of Navina Smart
timeFrame: 4 weeks
measure: Questionnaire Measuring Subjects' Compliance of Navina Smart
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse Events (AEs), Adverse Device Effects (ADEs), Serious Adverse Events (SAEs) Related to Navina Smart
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Neurologiska kliniken, Karolinska Universitetssjukhuset Solna
city: London
country: United Kingdom
facility: Gastrointestinal Physiology Unit, University College London Hospital
Study officials:
References: