To Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single-centre, prospective, open-label, single-arm pilot interventional clinical study
干预措施: TIES® Transcutaneous Implant Evacuation System (Device)
结局指标
主要结局
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period
时间窗: 16 Weeks
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period
次要结局
- Usability and patient satisfaction, assessed using structured questionnaires(16 weeks)
- Device performance and functionality, assessed by the ability to achieve controlled evacuation of bowel contents during the study period(16 weeks)
- Durability of the implant, assessed by device integrity and continued use over 16 weeks(16 weeks)
- Patient-reported quality of life, assessed using the Stoma-QoL questionnaire(16 weeks)
研究者
Mohan Ramchandani
Consultant Gastroenterology
Asian Institute of Gastroenterology, India