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| Name | Class |
|---|---|
| novoGI | INDUSTRY |
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Purpose: Evaluation of the CARâ„¢ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CARâ„¢ 27) device for creation of circular anastomoses during colonic or colorectal resection.
Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.
No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.
Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CARâ„¢ 27 device.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compression Anastomosis Ring: CARâ„¢ 27 | Device | Creation of anastomosis in colorectal surgeries using CARâ„¢ 27 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc. | 3-mo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yakov Khromov, Dr. | haemek medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HaEmek Medical Center | Afula | Israel |
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