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CompletedNCT01091155

COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
288 (actual)
Sponsor
novoGI · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

Detailed description

The proposed study is a post marketing study intended to gather and record additional data to further evaluate the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. The study objective is to evaluate the performance of the ColonRing™ in the creation of a circular anastomosis in colorectal procedures.

Conditions

Interventions

TypeNameDescription
DEVICEColonRing (Colorectal anastomosis)Creation of a colorectal compression anastomosis

Timeline

Start date
2010-03-01
Primary completion
2011-07-01
Completion
2011-07-01
First posted
2010-03-23
Last updated
2013-10-25
Results posted
2013-10-25

Locations

13 sites across 6 countries: United States, Austria, Belgium, Germany, Israel, Netherlands

Source: ClinicalTrials.gov record NCT01091155. Inclusion in this directory is not an endorsement.

COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study (NCT01091155) · Clinical Trials Directory