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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery
• Intervention / Treatment: Device: ColonRing (Colorectal anastomosis)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, A-1020
    • KH Barmherzig Brueder
• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
  • Leuven, Belgium, 3000
    • University Hospital Gasthuisberg
• Germany
  • Munich, Germany, 81737
    • Klinikum Neuperlach
• Israel
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
• Netherlands
  • Eindhoven, Netherlands, 5623EJ
    • Catharina Ziekenhuis
• United States
  • California
    • Irvine, California, United States
      • UCI Medical Center
    • Los-Angeles, California, United States
      • University of Southern California Health Sciences Campus
  • Florida
    • Orlando, Florida, United States, 32804
      • FPMG Center for Colon & Rectal Surgery
  • Georgia
    • Riverdale, Georgia, United States
      • Southern Regional Medical Center
  • Illinois
    • Evanston, Illinois, United States
      • NorthShore University Health System
  • Missouri
    • Springfield, Missouri, United States
      • Lester E. Cox Medical Center
    • St. Louis, Missouri, United States
      • St. Louis University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ColonRing TM	Device: ColonRing (Colorectal anastomosis); Creation of a colorectal compression anastomosis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: novoGI
• Collaborators: University of Southern California; University Hospital, Gasthuisberg; Catharina Ziekenhuis Eindhoven; Ziekenhuis Oost-Limburg; NorthShore University HealthSystem; Bnai Zion Medical Center; Lester E. Cox Medical Centers; Atlanta Colon & Rectal Surgery, Atlanta, GA; FPMG Center for Colon & Rectal Surgery; UCI Medical Center Irvine CA; St.Louis University hospital MO; Barmherzig Brueder; Klinikum Neuperlach

Publications and helpful links

Helpful Links

• Click here for more information about study device (sponsor's web site)

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: March 22, 2010
• First Posted (ESTIMATE): March 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Colorectal Surgery; Intestine; Colon Anastomosis; Rectum Anastomosis; Colorectal Anastomosis
• Other Study ID Numbers: Protocol COMPRES 23/11/2009