As of February 19, 2026, a single centre open, prospective pilot clinical study is registered to evaluate the safety and performance of the TIES Transcutaneous Implant Evacuation System in adults with permanent ileostomy or colostomy. The investigation is sponsored by the Asian Institute of Gastroenterology in India and is listed as not yet recruiting on ClinicalTrials.gov. The entry describes the conditions, the device under study, and the sponsor, with the public record available at the provided trial URL for review by clinical and regulatory teams.
In this article you will find a compact navigation block and a disciplined summary aligned with regulatory language. The content below synthesizes the facts from the source text and presents them in a neutral, evidence based manner for professionals involved in clinical quality and regulatory affairs.
What is the TIES Transcutaneous Implant Evacuation System study?
The record describes a single centre open and prospective pilot clinical study. It aims to assess the safety and performance of the TIES Transcutaneous Implant Evacuation System in patients requiring a permanent ileostomy or colostomy. The sponsor is the Asian Institute of Gastroenterology, India. The trial status is not yet recruiting. The source provides the device name and the patient population without detailing endpoints or statistical plans. The ClinicalTrials.gov link in the source text offers the public record for investigators and regulators to review the study scope.
How will safety and performance be evaluated?
The source states that the study will evaluate safety and performance of the device in the specified patient population. No additional methodological specifics are described in the source text. The not yet recruiting status indicates that enrollment has not commenced at the time the record was captured. This information comes directly from the ClinicalTrials.gov entry and the sponsor listing.
Who should care and why is this relevant to regulators and clinicians?
This early stage study centers on a transcutaneous ostomy device intended for use in patients with permanent ostomies. If recruitment proceeds, the resulting data could inform risk management documentation and future regulatory submissions related to intended use and device performance. For regulatory and quality teams, the record highlights the device name, patient population, study design, and sponsoring institution, all of which guide early engagement with clinical development and regulatory planning.
What is the current status and what might come next?
The source notes that the trial is not yet recruiting. If this status changes, the sponsor would likely update the record and begin enrollment at the identified centre. Regulators and stakeholders would monitor any amendments to endpoints, inclusion criteria, or safety monitoring plans via the ClinicalTrials.gov page and the sponsor communications.
FAQ
Q1 What is the device tested in this study Answer The study tests the TIES Transcutaneous Implant Evacuation System for use in permanent ostomies as described in the source.
Q2 Where is the study conducted Answer The Asian Institute of Gastroenterology in India is listed as the sponsor and site in the source text.
Q3 What is the design of the trial Answer It is described as a single centre open prospective pilot study.
Q4 Where can I find more information Answer The ClinicalTrials.gov record for NCT07413822 is provided in the source text and the link is included below in the announcement line.
Q5 What is the recruiting status Answer Not yet recruiting at the time of the source text.
Conclusion and implications
This pilot study constitutes an early evaluation of a transcutaneous ostomy device in a single centre. The available information confirms the device name, patient population, sponsor, and the upfront recruitment status. Stakeholders should track updates to the ClinicalTrials.gov record for changes in enrollment, endpoints, and safety findings that could influence regulatory discussions, labeling considerations, and patient care planning.
Disclaimer
This article summarizes information from the ClinicalTrials.gov record and related source text. It is not legal advice or regulatory guidance. For formal regulatory interpretation consult qualified counsel.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07413822?term=medical+device