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

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

Study Overview

• Status: Terminated
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Device: TIES® (Transcutaneous Implant Evacuation System)

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Gothenburgs University Hospital
  • Linköping, Sweden
    • Linköpings University Hospital
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • St James' University Hospital
  • Plymouth, United Kingdom, PL6 5FP
    • University Hospitals Plymouth NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject has ulcerative colitis, familial adenomatous polyposis coli or other diseases such as Crohn´s disease 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 pouch; and
• Patient is a male ≥18 years of age or female ≥18 years of age (See exclusion criterion 4 regarding female with childbearing potential); and
• Signed written informed consent has been obtained prior to any study- related procedure.

Exclusion Criteria:

• Concurrent gastrointestinal fistula, parastomal or incisional hernia, or a history of recurrent gastrointestinal fistula, recurrent parastomal hernia(s), and/or recurrent incisional hernia(s).
• Patients with undetermined colitis.
• An acute episode of Crohn´s disease occurring during the last three months before the operation
• Females who are of childbearing potential and do not wish to use birth control measures for the duration of the study
• Patients receiving immunosuppressives, oncologic treatment or anticoagulants.
• Any clinically significant, abnormal, baseline laboratory result which in the opinion of the surgeon, affects the patient's suitability for the study or puts the patient at risk if he/she undergoes surgery
• Severe illness which, in the opinion of the surgeon may put the patient at risk when participating in the study or may affect the patient's ability to complete the study visits
• Condition associated with the risk of poor protocol compliance, e.g. alcoholism and/or drug abuse, dementia, self-destructive personality disorder
• Subjects with BMI ≤ 17 kg/m2 or BMI ≥ 33 kg/m2
• Participate in other clinical studies that could interfere with the result in the ongoing study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single	Device: TIES® (Transcutaneous Implant Evacuation System); Transcutaneous Implant Evacuation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks	Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port.	24 weeks after implantation of the TIES® Port

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks	Absence of visible leakage or fecal staining of clothing at 16 weeks assessed in a diary	16 weeks
Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks	Absence of visible leakage or fecal staining of clothing at 36 weeks assessed in a diary	36 weeks
Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks	Absence of visible leakage or fecal staining of clothing at 52 weeks assessed in a diary	52 weeks
Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks	Proportion of implanted subjects using the TIES Lid for continence control at 16 weeks	16 weeks
Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks	Proportion of implanted subjects using the TIES Lid for continence control at 24 weeks	24 weeks
Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks	Proportion of implanted subjects using the TIES Lid for continence control at 36 weeks	36 weeks
Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks	Proportion of implanted subjects using the TIES Lid for continence control at 52 weeks	52 weeks
Subject's Preferences Regarding Maintaining Body Hygiene	Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste	52 weeks
Subject's Preferences Regarding Daily Activities	Number of subjects who found it easier using the TIES® Lid than using stoma bags for periodic emptying of waste	52 weeks
Subject's Preferences: Being Worried About Odor From Stoma	Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste	52 weeks
Subject's Preferences: Being Worried About Leakage From Stoma	Number of subjects who were less worried when using the TIES® Lid than when using stoma bags for periodic emptying of waste	52 weeks
Subject's Preferences: Recommending the TIES Solution	Number of subjects who would recommend the TIES solution to friends or family who need to undergo ileostomy	52 weeks

Collaborators and Investigators

• Sponsor: Ostomycure AB
• Collaborators: Devicia AB (now part of Veranex)
• Investigators: Study Director: Ludvig Linton, PhD, OstomyCure AS

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Implant; continence control; titanium
• Other Study ID Numbers: TIES® III C03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Currently no plan to share IPD but OstomyCure would be open to requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No