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Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.
Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).
Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MagDI System | Participants who underwent the MagDI System procedure and consented to participate in the Registry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Side-to-side duodenal-ileal anastomosis | Device | Side-to-side duodenal-ileal anastomosis formed by magnetic compression using the GT Metabolic MagDI System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Internal Hernia and Bowel Obstructions | To assess and characterize incidence and severity of internal hernia and bowel obstruction at one year in U.S. patients treated with the MagDI System compared with the pre-market study (GTM-001) and scientific literature. | From date of study index procedure through 360 days. |
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Inclusion Criteria:
Exclusion Criteria:
1. Participant does not provide informed consent to be enrolled and followed in the registry.
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All eligible patients in the U.S. who undergo a side-to-side duodeno-ileal anastomosis with the MagDI System.
| 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 |
|---|---|---|---|---|---|---|
| Ventura Advanced Surgical Associates | Recruiting | Ventura | California | 93003 | United States |
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| ID | Term |
|---|---|
| D000082122 | Internal Hernia |
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007410 | Intestinal Diseases |
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| Baptist Healthcare System, Inc. | Recruiting | Louisville | Kentucky | 40299 | United States |
|
| Ochsner Clinic Foundation | Recruiting | Lafayette | Louisiana | 70503 | United States |
|
| Bariatric Specialists of the Carolinas | Recruiting | Cary | North Carolina | 27518 | United States |
|
| Transform Weight Loss | Recruiting | Lynnwood | Washington | 98036 | United States |
|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |