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A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm - Standard of Care | No Intervention | The anastomosis will be created using Standard of Care only | |
| Device arm - Standard of Care + LifeSealâ„¢ Kit | Experimental | The anastomosis will be created using SOC + LifeSealâ„¢ Kit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LifeSealâ„¢ Kit | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events. | Up to 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Performance Rate of anastomotic leak (both radiological and clinical leaks) | Up to 15 weeks post procedure or at stoma closure, whichever comes first |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Ziekenhuis | Aalst | Belgium | ||||
| Ziekenhuis Oost-Limburg |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Genk |
| Belgium |
| University Hospital | Ghent | Belgium |
| UZ Leuven | Leuven | Belgium |
| Sourasky Medical Center | Tel Aviv | Israel |
| Skane University Hospital | Malmö | Sweden |
| Karolinska Institutet | Stockholm | Sweden |
| Uppsala University Hospital | Uppsala | SE-751 85 | Sweden |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |