Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy

Inclusion Criteria:

• Subject has ulcerative colitis, familial adenomatous polyposis coli or otherdiseases such as Crohn´s disease for whom a permanent ileostomy is indicated; or thesubject has a medical need for an alternative to an existing conventionalend-ileostomy, continent ileostomy or pelvic pouch; and

• Patient is a male ≥18 years of age or female ≥18 years of age (See exclusioncriterion 4 regarding female with childbearing potential); and

• Signed written informed consent has been obtained prior to any study- relatedprocedure.

Exclusion Criteria:

• Concurrent gastrointestinal fistula, parastomal or incisional hernia, or a historyof recurrent gastrointestinal fistula, recurrent parastomal hernia(s), and/orrecurrent incisional hernia(s).

• Patients with undetermined colitis.

• An acute episode of Crohn´s disease occurring during the last three months beforethe operation

• Females who are of childbearing potential and do not wish to use birth controlmeasures for the duration of the study

• Patients receiving immunosuppressives, oncologic treatment or anticoagulants.

• Any clinically significant, abnormal, baseline laboratory result which in theopinion of the surgeon, affects the patient's suitability for the study or puts thepatient at risk if he/she undergoes surgery

• Severe illness which, in the opinion of the surgeon may put the patient at risk whenparticipating in the study or may affect the patient's ability to complete the studyvisits

• Condition associated with the risk of poor protocol compliance, e.g. alcoholismand/or drug abuse, dementia, self-destructive personality disorder

• Subjects with BMI ≤ 17 kg/m2 or BMI ≥ 33 kg/m2

• Participate in other clinical studies that could interfere with the result in theongoing study