Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: 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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Ileostomy - Stoma Colostomy - Stoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIES® Transcutaneous Implant Evacuation System

Device

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 outcomes

  1. 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

    Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period

Secondary outcomes

  1. Device performance and functionality, assessed by the ability to achieve controlled evacuation of bowel contents during the study period

    Time frame: 16 weeks

  2. Durability of the implant, assessed by device integrity and continued use over 16 weeks

    Time frame: 16 weeks

  3. Patient-reported quality of life, assessed using the Stoma-QoL questionnaire

    Time frame: 16 weeks

  4. Usability and patient satisfaction, assessed using structured questionnaires

    Time frame: 16 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

DR G V RAO

CONTACT

[email protected]

+91-9182645727

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

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

Acronym: TIES IV

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.