Compression Anastomosis Using the CAR™ 27

Study Overview
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Brief Summary
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Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 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 CAR™ 27 device.

Official Title
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Compression Anastomosis Using the CAR™ 27

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Device: Compression Anastomosis Ring: CAR™ 27


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is over 18 years old. Patient is scheduled for a non-emergency procedure. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. Exclusion Criteria: Patient has an allergy to nickel. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease. Patient is participating in another clinical trial which may affect this study's outcomes. Patient has been taking regular steroid medication. Patient has contraindications to general anesthesia. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Compression Anastomosis Ring: CAR™ 27|Creation of anastomosis in colorectal surgeries using CAR™ 27|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon Anastomosis, Rectum Anastomosis, Intestine, Colorectal Surgery, Colorectal Anastomosis