A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
NCT ID: NCT01880918
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2012-10-31
2013-07-31
Brief Summary
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Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
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Detailed Description
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Conditions
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Study Design
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RETROSPECTIVE
Study Groups
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ColonRing
The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
3. Patient treated in routine clinical practice
4. Patient underwent his/her first follow-up visit within two months post-surgery
18 Years
ALL
No
Sponsors
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novoGI
INDUSTRY
Responsible Party
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Locations
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Florida Hospital, Center for Colon & Rectal Surgery
Atlamonte Springs, Florida, United States
18308 Murdock Circle, Suite 108
Port Charlotte, Florida, United States
CoxHealth Hospital, Colorectal Department
Springfield, Missouri, United States
Countries
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Facility Contacts
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Dr. Matthew Albert, MD
Role: primary
Kathleen Lueck
Role: backup
Dr. Jose Dominguez, MD
Role: primary
Other Identifiers
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RETROPRESS, CLPR-43-11-01
Identifier Type: -
Identifier Source: org_study_id
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