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

This study has been completed.
Sponsor:
Collaborators:
Atlanta Colon & Rectal Surgery
FPMG Center for Colon & Rectal Surgery
Lester E. Cox Medical Centers
UCI Medical Center Irvine CA
NorthShore University HealthSystem Research Institute
St.Louis University hospital MO
University of Southern California
Bnai Zion Medical Center
Barmherzig Brueder
Catharina Ziekenhuis Eindhoven
Ziekenhuis Oost-Limburg
University Hospital, Gasthuisberg
Klinikum Neuperlach
Information provided by (Responsible Party):
novoGI
ClinicalTrials.gov Identifier:
NCT01091155
First received: March 19, 2010
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Colorectal Surgery
Device: ColonRing (Colorectal anastomosis)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Further study details as provided by novoGI:

Primary Outcome Measures:
  • To Evaluate Rate of Anastomotic Leaks Related to the Use of the ColonRing™ Device, at 1 Month [ Time Frame: Approx. 1 year ] [ Designated as safety issue: Yes ]
    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.

  • Device Related Leak Rate up to 30 Days Post op [ Time Frame: 30 days post op ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure. [ Time Frame: 30 days post op ] [ Designated as safety issue: Yes ]

    The post operative parameters that will be measured during hospitalization period:

    1. 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
    2. First day to first postoperative flatus
    3. First day to first postoperative bowel movements
    4. First day of first postoperative toleration of liquids and solids (time to "keeping them down")


Enrollment: 288
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ColonRing TM Device: ColonRing (Colorectal anastomosis)
Creation of a colorectal compression 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091155

Locations
United States, California
UCI Medical Center
Irvine, California, United States
University of Southern California Health Sciences Campus
Los-Angeles, California, United States
United States, Florida
FPMG Center for Colon & Rectal Surgery
Orlando, Florida, United States, 32804
United States, Georgia
Southern Regional Medical Center
Riverdale, Georgia, United States
United States, Illinois
NorthShore University Health System
Evanston, Illinois, United States
United States, Missouri
Lester E. Cox Medical Center
Springfield, Missouri, United States
St. Louis University Hospital
St. Louis, Missouri, United States
Austria
KH Barmherzig Brueder
Vienna, Austria, A-1020
Belgium
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Germany
Klinikum Neuperlach
Munich, Germany, 81737
Israel
Bnai Zion Medical Center
Haifa, Israel, 31048
Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623EJ
Sponsors and Collaborators
novoGI
Atlanta Colon & Rectal Surgery
FPMG Center for Colon & Rectal Surgery
Lester E. Cox Medical Centers
UCI Medical Center Irvine CA
NorthShore University HealthSystem Research Institute
St.Louis University hospital MO
University of Southern California
Bnai Zion Medical Center
Barmherzig Brueder
Catharina Ziekenhuis Eindhoven
Ziekenhuis Oost-Limburg
University Hospital, Gasthuisberg
Klinikum Neuperlach
Investigators
Study Director: Eran Choman, Msc novoGI
  More Information

Additional Information:
No publications provided

Responsible Party: novoGI
ClinicalTrials.gov Identifier: NCT01091155     History of Changes
Obsolete Identifiers: NCT00859924
Other Study ID Numbers: Protocol COMPRES 23/11/2009
Study First Received: March 19, 2010
Results First Received: June 4, 2013
Last Updated: August 20, 2013
Health Authority: Austria: Ethikkommission
Belgium: Institutional Review Board
Germany: Ethics Commission
Netherlands: Independent Ethics Committee
Israel: Ethics Commission
United States: Institutional Review Board

Keywords provided by novoGI:
Colon Anastomosis
Rectum Anastomosis
Intestine
Colorectal Surgery
Colorectal Anastomosis

ClinicalTrials.gov processed this record on July 20, 2014