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New gut implant aims to tackle diabetes and obesity without surgery

NCT ID NCT07417683

Disease control Sponsor: Trans-Duodenal Concepts GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a temporary device placed in the upper small intestine to help control type 2 diabetes and obesity. The implant stays for 6 months and is then removed. Researchers will check if it lowers blood sugar (HbA1c), helps with weight loss, and improves liver health in people with MASH. About 126 adults will take part, with regular clinic visits and follow-up after removal.

What this could mean

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

Active substance
endoscopic implant (gastroduodenal bypass liner)
What this could lead to
If it works, this could offer a non-surgical, reversible option to help control diabetes and obesity, and possibly improve liver health in MASH patients.
What could go wrong
This is an early approval study with only 126 participants, so results may not apply to everyone. The implant requires endoscopic placement and removal, and there may be side effects or complications.

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 126 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

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: * Obese patients with type 2 diabetes mellitus, * Age ≥ 18 years, * The patient is able to understand the nature, significance, and scope of the clinical trial (MPDG §28), * The patient has been informed and all written consents from the patient are available. Exclusion Criteria: * The patient is mentally incapable of understanding the nature, objectives, or possible consequences of the clinical trial. * The patient is unwilling or unable to follow postoperative instructions. * The patient has been placed in an institution by court order or official order (MPDG §27). * The patient lives more than 100 km from the treatment site. * Pregnancy. * The patient is participating in another clinical trial in the field of diabetes management or metabolic syndrome.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

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

MASH Obesity Obesity type 2 diabetes mellitus Typ 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charite Universitätmedizin Berlin CVK

    Berlin, 13353, Germany

  • Klinikum St. Georg Leipzig

    Leipzig, Saxony, 04129, Germany

  • Knappschaft Kliniken Universitätsklinikum Bochum GmbH Medizinische Klinik

    Bochum, North Rhine-Westphalia, 44892, Germany

  • Sozialstiftung Bamberg

    Bamberg, Bavaria, 96049, Germany

  • Städtisches Klinikum Dresden

    Dresden, Saxony, 01067, Germany

  • University of Leipzig Medical Center, Department of Oncology, Gastroenterology, Hepatology and Pneumology

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080, Germany

  • Universitätsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167, Germany

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