Exploratory Investigation on a Novel Catheter

Inclusion criteria

• Provision of informed consent.
• Female and male aged 18-80 years.
• Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
• Patients considered suitable to participate by investigator.
• Able to read, write and understand information given to them regarding the study.

Exclusion criteria

• Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
• Previous enrolment in the present clinical investigation.
• Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
• Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
• Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
• Known anal or colorectal stenosis.
• Active inflammatory bowel disease.
• Acute diverticulitis.
• Colorectal cancer.
• Ischemic colitis.
• Any anal or colorectal surgery within the previous 3 months.
• Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
• Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
• Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.