Gastrointestinal Magnet System for Creating a Gastroenterostomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the performance and safety of the GT Metabolic Magnet System for producing a magnetic compression gastroenterostomy. The device is used to connect the stomach to the small intestine without sutures or staples, aiming to treat gastric outlet obstruction. Eligible participants have a GOO and require a gastroenterostomy, as determined by the treating investigator. The study excludes patients with certain prior surgeries, malignant causes that preclude the procedure, significant bleeding risks, or poor functional status. Conducted at General University Hospital in Prague, the trial assesses feasibility, safety, and potential procedural benefits of magnetic anastomosis in adults.

Why it matters

Who can join: the full rules

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 contraception for the duration of the study.
* Willing and able to comply with protocol requirements and provides written informed consent to participate in the study.

Exclusion Criteria:

* Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the gastroenterostomy procedure.
* If GOO due to malignant neoplasm:
* Baseline Eastern Cooperative Oncology Group (ECOG) \> 2 and/or Karnofsky 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 investigational 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.

Where it's running

• General University Hospital
  Prague, Czechia Recruiting

Study contacts

• Study coordinator: Lisa Griffin Vincent, PhD, MA
• Email: clinical@gtmetabolic.com
• Phone: +1 763-200-1416

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.