None listed
Conditions
Brief summary
The objective is to evaluate the safety and performance of the TIES system used to secure the evacuation of the ileum content. This device should provide a system with total absence or limited appearance of leakage when the lid is used and between two evacuations of the ileum content. The study subjects are patients with ulcerative colitis, familial adenomatous polyposis coli, other diseases requiring elective coloproctectomy with a permanent ileostomy, patients with a failing conventional or continent ileostomy
Interventions
Creation of a continent stoma with the TIES-III System in gastroenterological surgery. The system prevents seepage and eliminates the need for wearing an external appliance (e.g. pouch/bag) on the abdomen for collection of faeces or urine.
The duration of the intervention is similar to the duration of intervention for conventional ileostomy. Patients will be followed during 24 months after intervention.
Sponsors
OstomyCure AS
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient will be included if all of the following criteria are met: 1) Patient has an ulcerative colitis, familial adenomatous polyposis coli or any other diseases requiring elective coloproctectomy with a permanent ileostomy or Patient is already presenting a failing conventional or continent ileostomy or patient has an indication for permanent ileostomy 2) Patient is not suitable for pelvic pouch surgery 3) Patient is a male or female =18 years of age 4) Signed written informed consent has been obtained prior to any study related procedure
Exclusion criteria
Patient will not be included if any one of the following conditions exists: 1) Patient has been diagnosed with or was treated for a Crohn disease 2) Patient presenting a pathology with a long term immunosuppressive treatment (including corticoids) 3) Condition associated with the risk of poor protocol compliance, e.g. alcoholism or drug abuse 4) Participate in other clinical studies that could interfere with the result in the ongoing study 5) Females who are of childbearing potential and not taking adequate contraceptive precautions 6) Patients receiving an immunosuppressing medication or undergoing oncologic treatment 7) Patient with a medical history of fistula
Outcome results
None listed