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

Not Applicable

• Conditions: 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; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613000357752
• Lead Sponsor: OstomyCure AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified