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

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

Detailed Description
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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.

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

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Device: TIES® (Transcutaneous Implant Evacuation System)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single-arm multicentre open clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br> | Device: TIES® (Transcutaneous Implant Evacuation System)<br>* Transcutaneous Implant Evacuation System<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implant, continence control, titanium