Status:
TERMINATED
Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy
Lead Sponsor:
Ostomycure AB
Collaborating Sponsors:
Devicia AB (now part of Veranex)
Conditions:
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ileo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03416023
Start Date
October 30 2018
End Date
November 15 2023
Last Update
March 11 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Gothenburgs University Hospital
Gothenburg, Sweden
2
Linköpings University Hospital
Linköping, Sweden
3
St James' University Hospital
Leeds, United Kingdom, LS9 7TF
4
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom, PL6 5FP