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: Unknown
• 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 (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Not yet recruiting
    • Gothenburgs University Hospital
    • Contact: Jonas Bengtsson, MD, PhD; Email: jonas.l.bengtsson@vgregion.se
  • Linköping, Sweden
    • Recruiting
    • Linköpings University hospital
    • Contact: Pär Myrelid, MD, PhD; Email: par.myrelid@liu.se
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • St James' University Hospital
    • Contact: David Jayne, MD; Email: D.G.Jayne@leeds.ac.uk
  • Plymouth, United Kingdom, PL6 5FP
    • Recruiting
    • University Hospitals Plymouth NHS Trust
    • Contact: Sebastian Smolarek, MD; Email: sebastian.smolarek@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
Patient reported visual assessment	Visible leakage or fecal staining of clothing recorded on the 3-day diary Performance evaluation applies only among subjects with the TIES® Port in situ. Among subjects with the TIES® Port in situ, performance will be assessed according to (a) the proportion of subjects who use the TIES® Lid for continence control; (b) the proportion of subjects experiencing visible leakages around the implant; and (c) subject´s assessment on the ease of use of the TIES® Solution. The success criterion at 24 weeks requires at least 70% of subjects with the TIES® Port in situ having no visible leakage or staining of clothing adjacent to the implant between consecutive episodes of using the lid for continence control. Spillage that might occur at opening of the lid is not regarded as leakage.	24 weeks after implantation of the TIES® Port

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported visual assessment	Absence of visible leakage or fecal staining of clothing	16, 36 and 52 weeks
Patient diary_use of device	Use of TIES® Lid for continence control	16, 24, 36 and 52 weeks after implantation
VAS_usability assessment	Ease of use of the TIES® Lid using a visual analog scale	16, 24, 36 and 52 weeks after implantation
Patient reported preference	Subject´s preference for the TIES® solution or typical stoma bags	52 weeks after implantation
Device durability assessment	Evaluated by the cumulative proportion of subjects with the TIES® Port in situ	8,16, 24, 36 and 52 weeks
Treatment emergent adverse events	Defined as events with onset during or after the implantation procedure.	Procedure to 52 weeks
Peristomal skin lesions	Evaluated using a validated 5-point scale by assessing signs of erythema, erosion, or papular lesions. The classification of Borglund et al will be used to assess severity of the skin lesions the site. The scale combines erythematous and pseudoverrucous skin lesions assessments. Ranging from no signs (E0/P0) to severe erythematous-erosive skin lesions (E++/P0), to severe pseudoverrucous skin lesions (E0/P++).	Procedure to 52 weeks
Device-related adverse events		Procedure to 52 weeks
Device incidents	Proportion of implanted subjects with device incidents including; displacement, device revision and device replacement	Procedure to 52 weeks

Collaborators and Investigators

• Sponsor: Ostomycure AB
• Collaborators: Devicia AB
• Investigators: Study Director: Maria Klockare, OstomyCure AS

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): August 1, 2022

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): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

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