Safety, Performance and Durability of the TIES® Implant in Patients Requiring a Permanent Ileostomy

NCT03416023 | Terminated Results DMC

• 1 other identifier: TIES® III C03
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 4

Brief Summary

Study to assess the safety, performance and durability of the TIES® transcutaneous titanium implant in patients requiring a permanent ileostomy.

Conditions

Ileostomy - Stoma

Keywords

Implant; continence control; titanium

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks after implantation of the TIES® Port

Secondary Outcomes (12)

• Absence of Visible Leakage or Fecal Staining of Clothing at 16 Weeks

  16 weeks

• Absence of Visible Leakage or Fecal Staining of Clothing 36 Weeks

  36 weeks

• Absence of Visible Leakage or Fecal Staining of Clothing at 52 Weeks

  52 weeks

• Proportion of Implanted Subjects Using the TIES Lid at 16 Weeks

  16 weeks

• Proportion of Implanted Subjects Using the TIES Lid at 24 Weeks

  24 weeks

Study Arms (1)

Single

EXPERIMENTAL

Device: TIES® (Transcutaneous Implant Evacuation System)

Interventions

TIES® (Transcutaneous Implant Evacuation System) DEVICE

Transcutaneous Implant Evacuation System

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed written informed consent has been obtained prior to any study- related procedure.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostomycure AB: lead
• Devicia AB (now part of Veranex): collaborator

Study Sites (4)

Gothenburgs University Hospital

Gothenburg, Sweden

Location

Linköpings University Hospital

Linköping, Sweden

Location

St James' University Hospital

Leeds, LS9 7TF, United Kingdom

Location

University Hospitals Plymouth NHS Trust

Plymouth, PL6 5FP, United Kingdom

Location

Limitations and Caveats

The SARS-CoV-2 pandemic affected the recruitment rate, and the number of subjects who participated in and completed the investigation was few. Of those enrolled, there were many dropouts, e.g. due to leakage at the lid. The low number of evaluable study participants limited the assessment of the medical device performance.

Results Point of Contact

• Title: Johan Järte
• Organization: OstomyCure AS

jjaerte@ostomycure.com

+46 706 524 532

Study Officials

• Ludvig Linton, PhD

  OstomyCure AS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective single-arm multicentre open clinical study

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 30, 2018
• Study Start: October 30, 2018
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: March 11, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2); GB (2)