Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417

Status: Unknown status
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Florida
Florida Hospital, Center for Colon & Rectal Surgery
Recruiting
Atlamonte Springs
18308 Murdock Circle, Suite 108
Recruiting
Port Charlotte
Missouri
CoxHealth Hospital, Colorectal Department
Recruiting
Springfield
Time Frame
Start Date: October 2012
Completion Date: July 2013
Participants
Target number of participants: 200
Treatments
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.
Authors
Dr. Domingo E. Galiano Jr., Dr. Jose Dominguez, Dr. Matthew Albert
Sponsors
Leads: novoGI

This content was sourced from clinicaltrials.gov

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