COMpression anastomosis ring (CAR* 27/ColonRing*) Post maRketing Evaluation Study
- Conditions
- anastomosisreconnection between intestine10002112
- Registration Number
- NL-OMON34905
- Lead Sponsor
- iTi Surgical Solutions, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Subject is >= 18 years old.
2. BMI < 34.
3. Subject is planned to undergo a non-emergency (i.e., elective) operation with the creation of an anastomosis using the ColonRing*.
4. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
1. Subject has a known allergy to nickel.
2. 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.
3. Subject has participated in another clinical study which may affect this study*s outcomes within the last 30 days.
4. Subject's ASA (American Society of Anesthesiology) score 4 or 5.
5. Subject has a concurrent or previous invasive pelvic malignancy.
6. Subject has a systemic or incapacitating disease.
7. Subject has extensive local disease in the pelvis.
8. Subject requires more than one anastomosis during the surgery.
9. Women who are known to be pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study outcome is the rate of leaks.<br /><br>Anastomotic leakage will be defined as clinical symptoms such as fever or<br /><br>sepsis in combination with pelvic abscess, rectovaginal fistula or peritonitis<br /><br>within 30 days postoperatively leading to a clinical and * or radiological<br /><br>interventional procedure of the subject, or operation that confirms the leakage<br /><br>which has been determined to be related to the device. </p><br>
- Secondary Outcome Measures
Name Time Method