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 (TIES IV)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ileostomy - Stoma; Colostomy - Stoma
• Intervention / Treatment: Device: TIES® Transcutaneous Implant Evacuation System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DR G V RAO; Phone Number: +91-9182645727; Email: gvraoaig@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single-centre, prospective, open-label, single-arm pilot interventional clinical study

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period	Device feasibility, assessed by the incidence and nature of device-related and procedure-related adverse events during the 16-week follow-up period	16 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Usability and patient satisfaction, assessed using structured questionnaires	16 weeks

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TIES IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No