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

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ClinicalTrials.gov Identifier: NCT01091155
Recruitment Status : Completed
First Posted : March 23, 2010
Results First Posted : October 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Collaborators:
Atlanta Colon & Rectal Surgery, Atlanta, GA
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

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

Condition or disease Intervention/treatment Phase
Colorectal Surgery Device: ColonRing (Colorectal anastomosis) Phase 4

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  (Clinical Trial)
Actual Enrollment : 288 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
Study Start Date : March 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: ColonRing TM Device: ColonRing (Colorectal anastomosis)
Creation of a colorectal compression anastomosis



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

  2. Device Related Leak Rate up to 30 Days Post op [ Time Frame: 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.


Secondary Outcome Measures :
  1. Rate of Other Device Related Complications and Other Parameters During Hospitalization and Post Procedure. [ Time Frame: 30 days post op ]

    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")



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Atlanta, GA
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

Additional Information:
Responsible Party: novoGI
ClinicalTrials.gov Identifier: NCT01091155     History of Changes
Obsolete Identifiers: NCT00859924
Other Study ID Numbers: Protocol COMPRES 23/11/2009
First Posted: March 23, 2010    Key Record Dates
Results First Posted: October 25, 2013
Last Update Posted: October 25, 2013
Last Verified: August 2013

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