Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis

Completed

Conditions studied: Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative, Colostomy, Ileostomy - Stoma, Rectal Prolapse, Intestinal Polyposis, Lymphoma, Endometriosis, Intestinal Volvulus

In brief

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. 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.

Key facts

Study ID

NCT01301417

Run by

novoGI

People needed

171

Starts

2011-02-01

Expected to finish

2011-08-01

Last updated by the study team

2013-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient was > 18 years old at time of procedure
• Patient underwent an open or laparoscopic colorectal procedure with the creation of an anastomosis using the ColonRing™
• Patient treated in routine clinical practice following marketing clearance of the device within the cleared intended use
• Patient underwent his/her first follow-up visit within two months post-surgery

You may not qualify if…

• No exclusion criteria have been defined for this data collection.

Where it is running

• Southern Regional Medical Center — Riverdale, Georgia, United States

Full record on ClinicalTrials.gov

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