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| Name | Class |
|---|---|
| University Hospital, Gasthuisberg | OTHER |
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The purpose of this study is:
Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CARâ„¢ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARâ„¢ 27 | Experimental | Any patient with a diagnosis of colorectal cancer that has been previously radiated to the pelvic area (6-8 weeks prior to surgery) and that is electively scheduled for an open or laparoscopic total mesorectal excision (TME) and low anterior resection surgery (< 10cm from the anal verge) which requires the creation of an anastomosis, will be offered participation in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARâ„¢ 27 | Device | Creation of a low colorectal (side or pouch low rectal) compression anastomosis in previously radiated patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate for the occurrence of adverse events related to the use of the CARâ„¢ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months. | Approx. 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the creation of a functioning CARâ„¢ 27 anastomosis in radiated patients | Approx. 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andre D'Hoore, Professor | Contact | +32 (16) 344265 | andre.dhoore@uz.kuleuven.ac.be | |
| Yael Nir, MD | Contact | +972 (9) 8603000 | 3014 | yael@nitisurgical.com |
| Name | Affiliation | Role |
|---|---|---|
| Andre D'Hoore, Professor | Gasthuisberg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Gasthuisberg | Recruiting | Leuven | Belgium |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |