Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Transcutaneous Implant Evacuation System
Gothenburgs University Hospital
Gothenburg, Sweden
Linköpings University Hospital
Linköping, Sweden
St James' University Hospital
Leeds, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
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.
Time frame: 24 weeks after implantation of the TIES® Port
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 36 weeks
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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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 52 weeks