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

NCT07413822 | Not Yet Recruiting DMC

• 1 other identifier: TIES IV
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

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

  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 Outcomes (4)

• 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

Study Arms (1)

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

EXPERIMENTAL

Device: TIES® Transcutaneous Implant Evacuation System

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Central Study Contacts

DR G V RAO

CONTACT

+91-9182645727; gvraoaig@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterology

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share