A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
Status unconfirmed
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 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures. 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
- NCT01880918
- Run by
- novoGI
- People needed
- 200
- Starts
- 2012-10-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2013-06-19
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 a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
- Patient treated in routine clinical practice
- 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
- Florida Hospital, Center for Colon & Rectal Surgery — Atlamonte Springs, Florida, United States (enrolling)
- 18308 Murdock Circle, Suite 108 — Port Charlotte, Florida, United States (enrolling)
- CoxHealth Hospital, Colorectal Department — Springfield, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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