NCT03416023

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ostomycure AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ileostomy - Stoma

Interventions

Type	Name	Description
DEVICE	TIES® (Transcutaneous Implant Evacuation System)	Transcutaneous Implant Evacuation System

Timeline

• Start date: 2018-10-30
• Primary completion: 2023-11-15
• Completion: 2023-11-15
• First posted: 2018-01-30
• Last updated: 2025-03-11
• Results posted: 2025-02-17

Locations

4 sites across 2 countries: Sweden, United Kingdom