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

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

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.

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