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Evaluate the performance and safety of the GT Metabolic Magnet System for the creation of side-to-side compression anastomosis in the stomach and/or small bowel in conditions requiring an anastomosis as part of the underlying clinical treatment.
Evaluate the performance and safety of the Magnet System as a surgical tool for anastomosis in participants who have partial small bowel obstruction, SMAS, or GOO due to their similarities (they all involve a physical impediment (e.g., compression of the intestinal lumen) and/or mechanical blockage of the GI tract).
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| 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 anastomoses for intestinal diversion in subjects with small bowel obstruction, gastric outlet obstruction, or superior mesenteric artery syndrome. |
| Measure | Description | Time Frame |
|---|---|---|
| Magnet Placement | Placement and connection of two intraluminal Magnet. | 1 day |
| Natural Magnet Passage | Successful passage of magnets without surgical reintervention | 90 days |
| Anastomosis Patency | Creation of a patent anastomosis confirmed radiologically. | 90 days |
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Inclusion Criteria:
Indicated for gastrointestinal surgery requiring a gastric and/or small bowel anastomosis, without need for immediate lumen patency, and meets one of the following criteria:
Meets the surgical clearance requirements as governed by the investigator's institution.
If a child-bearing female, subject must commit to not becoming pregnant and agree to use contraception for the duration of the study.
Exclusion Criteria:
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| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmount Surgical Center | Recruiting | Westmount | Quebec | H3Z 2P9 | Canada |
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| ID | Term |
|---|---|
| D017219 | Gastric Outlet Obstruction |
| D013478 | Superior Mesenteric Artery Syndrome |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D004380 | Duodenal Obstruction |
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| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |