Evaluation of a Novel Electronic Transanal Irrigation System - Navina™ Smart

Launched by WELLSPECT HEALTHCARE · Mar 10, 2016

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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