Gastric Outlet ObstructionNCT07609511
Magnet System Gastric Outlet Obstruction Study
A study testing Magnet System in people with Gastric Outlet Obstruction, run by GT Metabolic Solutions, Inc. at 1 site in Czechia.
Trial summary
Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Outlet Obstruction
- What is being tested?
- Magnet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 9 Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital
Prague
David Michalský
David Michalsky, MD
About this study
Official title: Creation of Magnetic Compression Gastroenterostomy Using the GT Metabolic Solutions Magnet System in Adults With Gastric Outlet Obstruction (GOO): Magnet System GOO Study
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.
- Conditions
- Gastric Outlet Obstruction
- Being tested
- Magnet System
- Keywords
- Magnet System, GT Metabolic Solutions, Inc.
- Medical subject headings
- Gastric Outlet Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnet SystemDevice
Magnetic compression, side-to-side anastomosis, in patients with Gastric Outlet Obstruction and indicated for a gastroenterostomy
| Study group | Role | What they receive |
|---|---|---|
| Magnet System | Experimental | GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System") Receives: Device: Magnet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural Magnet Passage
Successful passage of magnets without invasive reintervention
Measured: 90 days
Anastomosis Patency
Creation of a patent anastomosis (confirmed by gastroscopy / endoscopy)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start9 Sep 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GT Metabolic Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609511
- Sponsor's protocol ID
- GTM-018
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of Magnetic Compression Gastroenterostomy Using the GT Metabolic Solutions Magnet System in Adults With Gastric Outlet Obstruction (GOO): Magnet System GOO Study
- ClinicalTrials.gov ID
- NCT07609511
- Acronym / sponsor ID
- GTM-018
- Conditions
- Gastric Outlet Obstruction
- Keywords
- Magnet System, GT Metabolic Solutions, Inc.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- GT Metabolic Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnet System | Experimental | Device: Magnet SystemGT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System") |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnet SystemMagnetic compression, side-to-side anastomosis, in patients with Gastric Outlet Obstruction and indicated for a gastroenterostomy | Device | Magnet System |
Primary outcome
Natural Magnet Passage
Time frame: 90 days
Successful passage of magnets without invasive reintervention
Anastomosis Patency
Time frame: 90 days
Creation of a patent anastomosis (confirmed by gastroscopy / endoscopy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnet System in people with Gastric Outlet Obstruction, run by GT Metabolic Solutions, Inc. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Griffin Vincent, PhD, MA (+1 763-200-1416, clinical@gtmetabolic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural Magnet Passage (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.