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Evaluate the performance and safety of the Magnet System to create anastomoses throughout the large bowel and between the large and distal small bowel.
The objective of the MagCR Study is to evaluate the performance and safety of the Magnet System in eligible participants with colorectal disease as either primary or the first stage of surgical treatment. A magnetic compression anastomosis is fully reversable and may be considered for temporary staging of surgical treatments. Reversal of the compression anastomosis may be easily performed given the Magnet System leaves no foreign material behind (e.g., sutures or staples).
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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 | Anastomoses throughout the large bowel and between the large and distal small bowel achieved by magnetic compression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnet Placement | Successful placement and connection of the Magnets | 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:
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 |
|---|---|---|---|---|---|---|
| Clinica MEDS La Dehesa SpA | Recruiting | Santiago | Chile |
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A 2-stage, open-label, multicenter study enrolling up to 60 subjects at up to 6 study centers in Europe and South America:
There will be a pause after completing enrollment and follow up to Day 30 for all Stage 1 subjects, with evaluation of safety by the independent Data Safety Monitoring Board (DSMB) to determine ability to move to the subsequent.
*Note: Evaluable subjects are enrolled subjects (signed ICF) who successfully undergo the study procedure. The total of 60 allows for attrition to hit the study goal of 50 evaluable subjects.
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| Policlinico San Marco, Bergamo | Recruiting | Bergamo | Italy |
|