Magnet System Gastric Outlet Obstruction Study

ConditionGastric Outlet Obstruction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorGT Metabolic Solutions, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior surgery, trauma, prostheses, disease or genetic expression which prevent or contraindicate the gastroenterostomy procedure.

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)

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Magnet SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Natural Magnet Passage

Successful passage of magnets without invasive reintervention

Time frame

90 days

Anastomosis Patency

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

Time frame

90 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GT Metabolic Solutions, Inc.

Lead sponsor

Source ClinicalTrials.gov

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