Prospective, multicentre, non randomized clinical study to investigate the safety and performance of the TIES III (Transcutaneous Implant Evacuation System) percutaneous titanium implant in patients undergoing surgery for permanent ileostomy or repair of a pre-existing permanent ileostomy

OstomyCure AS0 个研究点目标入组 20 人开始时间: 2013年4月4日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

OstomyCure AS