COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Study Overview
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Brief Summary
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The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

Detailed Description
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The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.

Official Title
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COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Device: ColonRing (Colorectal anastomosis)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years old. BMI < 34. Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing™. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures. Exclusion Criteria: Subject has a known allergy to nickel. Subject is planned to undergo an emergency procedure or has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel,carcinomatosis. Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days. Subject's ASA (American Society of Anesthesiology) score 4 or 5. Subject has a concurrent or previous invasive pelvic malignancy. Subject has a systemic or incapacitating disease. Subject has extensive local disease in the pelvis. Subject requires more than one anastomosis during the surgery. Women who are known to be pregnant.

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ColonRing TM<br> | Device: ColonRing (Colorectal anastomosis)<br>* Creation of a colorectal compression anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month | Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device. | Approx. 1 year | 
| Device Related Leak Rate up to 30 Days Post op | Anastomotic leakage will be defined as clinical symptoms such as fever or sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis within 30 days postoperatively leading to a clinical and / or radiological interventional procedure of the subject, or operation that confirms the leakage which has been determined to be related to the device. | 30 days post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure. | The post operative parameters that will be measured during hospitalization period: Hospitalization time (two dates will be recorded: ready for discharge and discharge). The later noting where the subject was discharged to - e.g. nursing home or home First day to first postoperative flatus First day to first postoperative bowel movements First day of first postoperative toleration of liquids and solids (time to keeping them down) | 30 days post op | 

 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