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Assessment of Colonic Oxygenation Utilizing Intra.OxTM

Clinical Trial Details

The purpose of this study is to calculate the amount of oxygen in bowel tissue with the ViOptix Intra.Ox™ device. The creation of a healthy and safe colorectal anastomosis, where the colon is attached to the remainder of the rectum after a portion of it has been removed, requires good blood supply and oxygenation to the bowel tissue. The device in this study is intended to non-invasively measure the percent of oxygen in the bowel tissue.

The Intra.Ox™ device has already been cleared by the U.S. Food and Drug Administration (FDA) to calculate oxygen levels in bowel tissue based on its similarity in structure and function to previously used devices.

The Intra.Ox™ device will be used during left sided open, laparoscopic or robotic colonic resection for either diverticular disease or colorectal cancer.

This research study is being done because there are currently no published studies that measure how much oxygen is in the diseased tissue of patients with diverticulitis or colon cancer compared to healthy parts of their colon. We think that learning if there is a difference in the amount of oxygen in these areas will help us better understand healing and risks for certain complications.

Key Eligibility: 
  1. Male or female over the age of 18   
  2. Documentation of a required left sided open, laparoscopic or robotic colonic resection for either diverticular disease or colorectal cancer

Detailed eligibility will be discussed when reaching out to the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Rohit Rasane
646-962-2789
rkr4004@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2109023980

Status

Open to Enrollment

Age Group

Adult

Sponsor