Prospective multicentre open clinical study to assess the safetyperformance and durability of the TIESÂ® transcutaneous titaniumimplant in patients requiring a permanent ileostomy - TIESÂ® III C03

OstomyCure AS0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年2月6日

试验速览

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•1) Subject has ulcerative colitis, familial adenomatous polyposis coli or other diseases for
•whom a permanent ileostomy is indicated; or the subject has a medical need for an alternative to an existing conventional end-ileostomy, continent ileostomy or pelvic
•2) Patient is a male >=18 years of age or female >=18 years of age (note exclusion criterion
•4 regarding female with childbearing potential); and
•3) Signed written informed consent has been obtained prior to any study- related

•1) Concurrent gastrointestinal fistula, parastomal or incisional hernia, or a history of
•recurrent gastrointestinal fistula, recurrent parastomal hernia(s), and/or recurrent
•incisional hernia(s).
•2) Patients with undetermined colitis.
•3) Patients with CrohnÂ´s disease
•4) Females who are of childbearing potential and do not wish to use birth control
•measures for the duration of the study
•5) Patients receiving immunosuppressives, oncologic treatment or anticoagulants.
•6) Any clinically significant, abnormal, baseline laboratory result which in the opinion of
•the surgeon, affects the patientâ??s suitability for the study or puts the patient at risk if
•he/she undergoes surgery
•7) Severe illness which, in the opinion of the surgeon may put the patient at risk when
•participating in the study or may affect the patientâ??s ability to complete the study visits
•8) Condition associated with the risk of poor protocol compliance, e.g. alcoholism and/or
•drug abuse, dementia, self-destructive personality disorder
•9) Subjects who are underweight or obese with BMI <= 17 kg/m2 or BMI >= 33 kg/m2
•10) Participate in other clinical studies that could interfere with the result in the ongoing

发起方

OstomyCure AS