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

Ileostomy - Stoma Clinical Trial

Official title:
Prospective Multicentre Open Clinical Study to Assess the Safety Performance and Durability of the TIES® Transcutaneous Titanium Implant in Patients Requiring a Permanent Ileostomy

Clinical Trial Summary

Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.

Clinical Trial Description

This is a multicentre, open-label, single-arm clinical study that will assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy (a surgical procedure that involves connecting the small intestine to the skin to create an opening). The Transcutaneous Implant Evacuation System (TIES®) is a medical device designed to enable continence control for patients who would otherwise need to wear an ileostomy bag. Eligible subjects will undergo a conventional ileostomy procedure under general anaesthesia and have the TIES® Port implanted. To date, the TIES® has been evaluated in 11 patients in 2 clinical studies. This study aims to collect more data that will assess performance, durability, safety and the impact that the TIES® has on a patient's quality of life. The study will enroll 50 patients across Europe that require a permanent ileostomy, including patients with ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease. Study subjects are expected to participate for approximately 1 year following surgical placement of the TIES® Port. Participation will involve a screening period, surgical implantation of the device (in-patient) and scheduled follow-up assessments out to 1 year post implant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03416023
Study type Interventional
Source Ostomycure AB
Contact
Status Terminated
Phase N/A
Start date October 30, 2018
Completion date November 15, 2023
View Details
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