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The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CG-100 device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CG-100 device | Device | Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse events, and device related complications | During surgical procedure and up to 30 days (+/- 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of anastomotic leakage when the CG-100 is used | Up until device removal day (10 days +/-1) | |
| Position of the device (internal sheath) | Device removal day (10 days +/-1) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium | |||
| UZ Gent |
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| Assessment of the device's application technique ease of placement and extraction of the device performance |
| Device removal day (10 days +/-1) |
| Determine subject tolerability of the device | Device removal day (10 days +/- 1) |
| Ghent |
| 9000 |
| Belgium |
| KBC Zagreb | Zagreb | 10000 | Croatia |
| Jahn Ferenc Hospital | Budapest | 1204 | Hungary |
| National Institute of Oncology | Budapest | H-112 | Hungary |
| Soroka Medical Center | Beersheba | 85025 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Assuta Medical Center | Tel Aviv | 69710 | Israel |