Clinical trial NCT03416023: Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: Implant
continence control
titanium
Lead sponsor: Ostomycure AB
Sponsor class: INDUSTRY
Collaborators: name: Devicia AB (now part of Veranex)
First posted: 2018-01-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-arm multicentre open clinical study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Absence of Visible Leakage or Fecal Staining of Clothing at 24 Weeks
timeFrame: 24 weeks after implantation of the TIES® Port
Secondary outcomes:
measure: Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks
timeFrame: 16 weeks
measure: Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks
timeFrame: 36 weeks
measure: Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks
timeFrame: 52 weeks
measure: Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks
timeFrame: 16 weeks
measure: Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks
timeFrame: 24 weeks
measure: Proportion of Implanted Subjects Using the TIES Lid at 36 Weeks
timeFrame: 36 weeks
measure: Proportion of Implanted Subjects Using the TIES Lid at 52 Weeks
timeFrame: 52 weeks
measure: Subject's Preferences Regarding Maintaining Body Hygiene
timeFrame: 52 weeks
measure: Subject's Preferences Regarding Daily Activities
timeFrame: 52 weeks
measure: Subject's Preferences: Being Worried About Odor From Stoma
timeFrame: 52 weeks
measure: Subject's Preferences: Being Worried About Leakage From Stoma
timeFrame: 52 weeks
measure: Subject's Preferences: Recommending the TIES Solution
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Gothenburgs University Hospital
city: Linköping
country: Sweden
facility: Linköpings University Hospital
city: Leeds
country: United Kingdom
facility: St James' University Hospital
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
affiliation: OstomyCure AS
name: Ludvig Linton, PhD
role: STUDY_DIRECTOR
References: