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

N/ANot Yet RecruitingNCT07413822

Asian Institute of Gastroenterology, India10 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Ileostomy - Stoma Colostomy - Stoma

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts