Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Magnetic compression, side-to-side anastomosis, in patients with Gastric Outlet Obstruction and indicated for a gastroenterostomy
General University Hospital
Prague, Czechia
RECRUITINGNatural 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
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