Magnet System Gastric Outlet Obstruction Study
Creation of Magnetic Compression Gastroenterostomy Using the GT Metabolic Solutions Magnet System in Adults With Gastric Outlet Obstruction (GOO): Magnet System GOO Study
1 other identifier
interventional
10
1 country
1
Brief Summary
Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2026
CompletedFirst Posted
Study publicly available on registry
May 27, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 27, 2026
May 1, 2026
5 months
May 18, 2026
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Natural Magnet Passage
Successful passage of magnets without invasive reintervention
90 days
Anastomosis Patency
Creation of a patent anastomosis (confirmed by gastroscopy / endoscopy)
90 days
Study Arms (1)
Magnet System
EXPERIMENTALGT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System")
Interventions
Magnetic compression, side-to-side anastomosis, in patients with Gastric Outlet Obstruction and indicated for a gastroenterostomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General University Hospital
Prague, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2026
First Posted
May 27, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 27, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share