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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period [Срок оценки: 16 Weeks]

Вторичные конечные точки (4)

• Device performance and functionality, assessed by the ability to achieve controlled evacuation of bowel contents during the study period [Срок оценки: 16 weeks]
• Durability of the implant, assessed by device integrity and continued use over 16 weeks [Срок оценки: 16 weeks]
• Patient-reported quality of life, assessed using the Stoma-QoL questionnaire [Срок оценки: 16 weeks]
• Usability and patient satisfaction, assessed using structured questionnaires [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07413822 · TIES IV

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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