Health Condition 1: K638- Other specified diseases of intestine
Conditions
Interventions
Intervention1: TIES® (Transcutaneous Implant Evacuation System): The TIES® system is composed of the TIES® Port, TIES® Surgical Aids, TIES® Stabilizer and TIES® Lid and Bag Holder.
Only the TIES® Por
Sponsors
OstomyCure AS
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subject has ulcerative colitis, familial adenomatous polyposis coli or other diseases 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 2) Patient is a male =18 years of age or female =18 years of age (note exclusion criterion 4 regarding female with childbearing potential); and 3) Signed written informed consent has been obtained prior to any study- related procedure.
Exclusion criteria
Exclusion criteria: 1) Concurrent gastrointestinal fistula, parastomal or incisional hernia, or a history of recurrent gastrointestinal fistula, recurrent parastomal hernia(s), and/or recurrent incisional hernia(s). 2) Patients with undetermined colitis. 3) Patients with Crohn´s disease 4) Females who are of childbearing potential and do not wish to use birth control measures for the duration of the study 5) Patients receiving immunosuppressives, oncologic treatment or anticoagulants. 6) 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 7) 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 8) Condition associated with the risk of poor protocol compliance, e.g. alcoholism and/or drug abuse, dementia, self-destructive personality disorder 9) Subjects who are underweight or obese with BMI = 17 kg/m2 or BMI = 33 kg/m2 10) Participate in other clinical studies that could interfere with the result in the ongoing study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port. 2.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.Timepoint: Week 4, Week 8, Week 16, Week 24, Week 36 and week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absence of visible leakage or fecal staining of clothing at 16, 36 and 52 weeks. 2. Proportion of implanted subjects using the TIES® Lid for continence control at 16, 24, 36 and 52 weeks. 3. Subject´s assessment on the ease of use of the TIES® Lid using a visual analog scale 16, 24, 36 and 52 weeks after implantation. 4.Subject´s preference for the TIES® solution assessed at 52 weeks. Timepoint: Week 16, Week 24, Week 36 and week 52 | — |
Countries
Austria, India, Norway, Poland, Sweden, United Kingdom
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Private Limited
Outcome results
None listed