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New implant could replace stoma bags for bowel control

NCT ID NCT07413822

Disease control Sponsor: Asian Institute of Gastroenterology, India Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests a new device called TIES® that is surgically implanted in the abdomen to help people with a permanent ileostomy or colostomy control when they empty their bowels. Ten adults will receive the implant during a stoma revision surgery and be followed for 16 weeks to check safety, how well it works, and its effect on quality of life. The goal is to see if this device can be a better alternative to traditional stoma bags.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TIES® Transcutaneous Implant Evacuation System (a surgically implanted device)
What this could lead to
If it works, this could offer a more convenient and controlled way to manage bowel movements for people with a permanent stoma, potentially improving their daily life.
What could go wrong
This is a very early, small pilot study with only 10 participants, so results may not apply to everyone. There are risks of infection, device failure, or complications from surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colostomy - stoma Ileostomy - stoma

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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