Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
Status: | Recruiting |
---|---|
Conditions: | Colorectal Cancer, Cancer, Colitis, Lymphoma, Women's Studies, Gastrointestinal, Crohns Disease, Endometriosis |
Therapuetic Areas: | Gastroenterology, Oncology, Other, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/27/2013 |
Start Date: | February 2011 |
a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- No exclusion criteria have been defined for this data collection.
We found this trial at
1
site
Southern Regional Medical Center Southern Regional Medical Center (SRMC) is a 331-bed full-service hospital managed...
Click here to add this to my saved trials