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Not yet recruiting NCT07413822

A Single-centre Open, Prospective, Pilot Clinical Study to Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy

No phase Interventional Ileostomy - Stoma Colostomy - Stoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TIES® Transcutaneous Implant Evacuation System.
Who it may be relevant to
Registry conditions: Ileostomy - Stoma, Colostomy - Stoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

To Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy

Overview

This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or colostomy. Eligible patients will undergo surgical implantation of the TIES® Port as part of stoma revision. Participants will be followed for 16 weeks post-implantation to assess device safety, tissue ingrowth and healing, performance, durability, and impact on quality of life. Safety will be evaluated through monitoring of adverse events, while performance and usability will be assessed using structured questionnaires and clinical assessments. Quality of life will be measured using the validated Stoma-QoL questionnaire. The study aims to generate clinical evidence on the feasibility and safety of the TIES® system as an alternative to conventional stoma management.

Interventions

  • Device TIES® Transcutaneous Implant Evacuation System
    The intervention involves surgical implantation of the TIES® Transcutaneous Implant Evacuation System in patients with a permanent ileostomy or colostomy. The device is implanted through the abdominal wall as part of a stoma revision procedure to allow controlled evacuation of bowel contents. Following implantation, participants will be followed up for assessment of device safety, tissue integration, functionality, and patient-reported outcomes over the study period.

Primary outcome measures

  • Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period [Time frame: 16 Weeks]
Secondary outcome measures (4)
  • Device performance and functionality, assessed by the ability to achieve controlled evacuation of bowel contents during the study period [Time frame: 16 weeks]
  • Durability of the implant, assessed by device integrity and continued use over 16 weeks [Time frame: 16 weeks]
  • Patient-reported quality of life, assessed using the Stoma-QoL questionnaire [Time frame: 16 weeks]
  • Usability and patient satisfaction, assessed using structured questionnaires [Time frame: 16 weeks]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 75 years
  • Patients requiring a permanent ileostomy or colostomy
  • Planned for stoma revision surgery with implantation of the TIES® system
  • Ability to understand the study procedures and comply with follow-up visits
  • Willingness to provide written informed consent

Exclusion criteria

  • Age below 18 years or above 75 years
  • Temporary stoma or planned stoma reversal
  • Active abdominal or peristomal infection at the time of surgery
  • Severe uncontrolled systemic illness that may increase surgical risk
  • Known allergy or hypersensitivity to device materials
  • Pregnancy or lactation
  • Participation in another interventional clinical study within the last 30 days
  • Any condition which, in the opinion of the investigator, makes the patient unsuitable for the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07413822 · TIES IV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗