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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ileostomy - Stoma
• Colostomy - Stoma

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-05-30
• Completion: 2028-05-30
• First posted: 2026-02-17
• Last updated: 2026-02-17