A clinical study to assess the safety, performance and durability of medical device TIES® in Patients requiring permanent ileostomy.
- Conditions
- Health Condition 1: K638- Other specified diseases of intestine
- Registration Number
- CTRI/2021/11/038066
- Lead Sponsor
- OstomyCure AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 patientâ??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 patientâ??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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Absence of visible leakage or fecal staining of clothing at 24 weeks after implantation of the TIES® Port. <br/ ><br>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 Outcome Measures
Name Time Method 1. Absence of visible leakage or fecal staining of clothing at 16, 36 and 52 weeks. <br/ ><br>2. Proportion of implanted subjects using the TIES® Lid for continence control at 16, 24, 36 and 52 weeks. <br/ ><br>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. <br/ ><br>4.Subject´s preference for the TIES® solution assessed at 52 weeks. <br/ ><br>Timepoint: Week 16, Week 24, Week 36 and week 52