COMPRES - COMpression anastomosis ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Study Description:

COMPRES is a post marketing study intended to gather and record clinical data to further evaluate the performance of the ColonRing™ device in the creation of a circular anastomosis in colorectal procedures.

Study Hypothesis:

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

Study Design:

An Intervention Model with a Single Group Assignment, Open Label, Prospective, Multi Center.

Primary Outcome Measures:

• Rate of leaks

Secondary Outcome Measures:

• Rate of other complications and parameters during hospitalization and post procedure
• Length of time and ease of surgical procedure
• Ring expulsion time and awareness 

Estimated Enrollment:

Up to 400 patients to reach the primary endpoint. The sample size will be determined by the rate of leaks in LAR procedures lower than 10 cm from the anal verge.

Study Start Date:

March 2010

Eligibility

Age 18 years and older.
Genders eligible for study:   Both
Patients scheduled for an elective colorectal procedure

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 Operations

Sites:

1. Atlanta Colon & Rectal Surgery, Riverdale, GA
2. Barmherzige Brüder, Vienna, Austria
3. Bnai Zion Medical Center, Haifa, Israel
4. Catharina Ziekenhuis, Eindhoven, Holland
5. FPMG Center for Colon & Rectal Surgery, Orlando, FL
6. Klinikum Neuperlach, Munich, Germany
7. Lester E. Cox Medical Centers, Springfield, MO
8. Northshore University Health System Research Institute, Chicago, IL
9. St. Louis University Hospital, St. Louis, MO
10. UCI Medical Center, Irvine, CA
11. University of Southern California, LA, CA
12. University Hospital, Gasthuisberg, Leuven, Belgium
13. Ziekenhuis Oos-Limburg, Campus St. -Jan, Genk, Belgium

Study Data and Quality Management:

CRO - MedTrials, Dallas, TX
A full-service contract research organization, serves as a provider of specialized clinical research services.

Data Management – Medidata Solutions, Uxbridge, UK
A leading global provider of SaaS clinical development solutions.

 

Quality and Data Monitoring (QASM) Committee:

The QASM committee is responsible for reviewing all study's serious adverse events. 

Dr. Steven Wexner -  Cleveland Clinic, Florida, USA. 
Dr. Steven Wexner served as the Chief of Staff at Cleveland Clinic Hospital from 1997-2007 and since 2007 has been the Chief Academic Officer.  He is also the Chairman of the Department of Colorectal Surgery, and holds numerous academic appointments at leading institutions around the globe. 

Prof. Lars Påhlman - University Hospital, Uppsala, Sweden
Prof. Lars Påhlman is a Professor of Surgery and Head of the Colorectal Unit at the
Department of Surgery at University Hospital, Uppsala, Sweden. From the late
1980s onwards he has been involved with numerous, large randomized trials.

Study Status to date:

Over 70% of enrollment completed.

Demographics

Age – 60±13.3 (25-89), Median-62
Men / Women – 50% / 50%
BMI - 26±4.0 (15-34), Median-26

Subject Disposition by Type of the Procedure

Procedure Type	Percent
Anterior Resection	24.8
Closure of Colostomy	1.0
Left Hemicolectomy	3.0
Low Anterior Resection	40.1
Other	0.5
Right Hemicolectomy	5.0
Sigmoidectomy	21.3
Subtotal Colectomy	1.0
Total Colectomy	3.5

 

Further information

If you are interested in learning more about the ColonRing™, please contact us.

Please go to the Clinical Trials page for updated information.