COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study
NCT ID: NCT01091155
Last Updated: 2013-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
288 participants
INTERVENTIONAL
2010-03-31
2011-07-31
Brief Summary
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Detailed Description
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The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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ColonRing TM
ColonRing (Colorectal anastomosis)
Creation of a colorectal compression anastomosis
Interventions
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ColonRing (Colorectal anastomosis)
Creation of a colorectal compression anastomosis
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Atlanta Colon & Rectal Surgery, Atlanta, GA
OTHER
FPMG Center for Colon & Rectal Surgery
UNKNOWN
Lester E. Cox Medical Centers
OTHER
UCI Medical Center Irvine CA
UNKNOWN
Endeavor Health
OTHER
St.Louis University hospital MO
UNKNOWN
University of Southern California
OTHER
Bnai Zion Medical Center
OTHER_GOV
Barmherzig Brueder
UNKNOWN
Catharina Ziekenhuis Eindhoven
OTHER
Ziekenhuis Oost-Limburg
OTHER
University Hospital, Gasthuisberg
OTHER
Klinikum Neuperlach
UNKNOWN
novoGI
INDUSTRY
Responsible Party
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Principal Investigators
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Eran Choman, Msc
Role: STUDY_DIRECTOR
novoGI
Locations
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UCI Medical Center
Irvine, California, United States
University of Southern California Health Sciences Campus
Los Angeles, California, United States
FPMG Center for Colon & Rectal Surgery
Orlando, Florida, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
NorthShore University Health System
Evanston, Illinois, United States
Lester E. Cox Medical Center
Springfield, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
KH Barmherzig Brueder
Vienna, , Austria
Ziekenhuis Oost Limburg
Genk, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Klinikum Neuperlach
Munich, , Germany
Bnai Zion Medical Center
Haifa, , Israel
Catharina Ziekenhuis
Eindhoven, , Netherlands
Countries
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Related Links
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Click here for more information about study device (sponsor's web site)
Other Identifiers
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Protocol COMPRES 23/11/2009
Identifier Type: -
Identifier Source: org_study_id
NCT00859924
Identifier Type: -
Identifier Source: nct_alias