ClinicalTrials.gg
RecruitingNCT07609511Updated Sep 14, 2026

Magnet System Gastric Outlet Obstruction Study

An interventional study of Magnet System in Gastric Outlet Obstruction, sponsored by GT Metabolic Solutions, Inc.. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by GT Metabolic Solutions, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).

Read the detailed description

The purpose of this clinical research study is to evaluate performance and safety of the GT Metabolic Magnet System for creation of a side-to-side gastroenteral anastomosis in adults. The Magnet System is a surgical tool and is intended for use in clinical procedures requiring an anastomosis. Gastroenterostomy for gastric outley obstruction (GOO) is one example of a clinical procedure requiring a gastroenteral anastomosis. Gastroenterostomy is most often created today using incisions and sutures or staples. This study explores creation of a gastroenterostomy with magnetic compression anastomosis.

02

Conditions studied

  • Gastric Outlet Obstruction

Keywords

  • Magnet System
  • GT Metabolic Solutions, Inc.
03

In context

Gastric Outlet Obstruction

38 studies on the registry are indexed under Gastric Outlet Obstruction; 14 are open to participants now.

This study's planned enrollment of 10 is below the median of 69 across 28 interventional studies indexed under Gastric Outlet Obstruction.

Browse Gastric Outlet Obstruction studies →

Lead sponsor

GT Metabolic Solutions, Inc. is the lead sponsor of 14 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Gastric outlet obstruction (GOO) and indicated for a gastroenterostomy, per the discretion of the treating investigator.
  • If a child-bearing female, subject must commit to not becoming pregnant and agree to use for the duration of the study.
  • Willing and able to comply with protocol requirements and provides written to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the gastroenterostomy procedure.
  • If GOO due to malignant neoplasm:
  • Baseline (ECOG) > 2 and/or Performance score \< 30
  • Gastric or intestinal cancer or malignant infiltration precluding creation of a magnetic compression anastomosis (per investigator discretion)
  • Coagulation disorders, on continuous or complete anticoagulation, or other conditions associated with high risk of bleeding and not correctable or manageable, precluding creation of a magnetic compression anastomosis (per investigator discretion)
  • Any anomaly precluding orogastric access by endoscope and catheters, and manipulation techniques.
  • Implantable pacemaker or defibrillator.
  • Woman who is either pregnant or breast feeding.
  • Any comorbidity or current status of subject's physiological fitness that in the surgeon's or anesthesiologist's opinion represents safety concerns that make the subject medically unfit for the procedure, including any significant congenital or acquired anomalies of the GI tract at or distal to the placement of the Magnets.
  • Unhealed ulcers, bleeding lesions, tumor, or any other lesion at target Magnet deployment sites.
  • Expected need for Magnetic Resonance Imaging (MRI) within the first 2 months after the procedure.
  • Any anomaly preventing/contraindicating endoscopic or laparoscopic access and procedures.
  • Active infections requiring antibiotic therapy, unless resolved before undergoing the study procedure.
  • Unable to comply with the follow-up schedule and assessments.
  • Known allergies to the device components or contrast media.
  • Currently participating in another clinical research study with an drug or medical device.
  • Any condition that, in the investigator's opinion, may preclude completion of follow-up assessments through Day 90 (e.g., a medical condition that may increase the risk associated with study participation or may interfere with interpretation of study results, inability to adhere to the visit schedule, or poor compliance with treatment regimen.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Magnet System

    GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")

    Device: Magnet System

Interventions

  • DeviceMagnet System

    Magnetic compression, side-to-side anastomosis, in patients with Gastric Outlet Obstruction and indicated for a gastroenterostomy

06

What researchers measure

Primary outcomes

  1. Natural Magnet Passage

    Successful passage of magnets without invasive reintervention

    Time frame: 90 days

  2. Anastomosis Patency

    Creation of a patent anastomosis (confirmed by gastroscopy / endoscopy)

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • General University Hospital
    Prague, Czechia
    Recruiting
    • David Michalský · Contact
    • David Michalsky, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07609511
Lead sponsor
GT Metabolic Solutions, Inc.
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Sep 9, 2026
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Lisa Griffin Vincent, PhD, MA
Contact
clinical@gtmetabolic.com
+1 763-200-1416
Josh Schumacher
Contact
clinical@gtmetabolic.com
+1 763-200-1416

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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