Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnet System | Experimental | GT Metabolic Magnet System comprised of GT Metabolic Magnet System ("Magnet System") |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnet System | Device | Magnetic compression, side-to-side anastomosis, in patients with Gastric Outlet Obstruction and indicated for a gastroenterostomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Griffin Vincent, PhD, MA | Contact | +1 763-200-1416 | clinical@gtmetabolic.com | |
| Josh Schumacher | Contact | +1 763-200-1416 | clinical@gtmetabolic.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital | Prague | Czechia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided