Third Eye Retroscope Randomized Clinical Evaluation

Completed · Not applicable

Conditions studied: Colorectal Neoplasms

In brief

The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone. Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first. Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.

Key facts

Study ID

NCT01044732

Run by

Avantis Medical Systems

People needed

448

Starts

2009-03-01

Expected to finish

2010-02-01

Last updated by the study team

2017-07-25

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
• The patient must understand and provide written consent for the procedure.

You may not qualify if…

• Patients with a history of colonic resection;
• Patients with inflammatory bowel disease;
• Patients with a personal history of polyposis syndrome;
• Patients with suspected chronic stricture potentially precluding complete colonoscopy;
• Patients with diverticulitis or toxic megacolon;
• Patients with a history of radiation therapy to abdomen or pelvis;
• Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Kansas City Veterans Administration Medical Center — Kansas City, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Bayside Endoscopy Center — Providence, Rhode Island, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Cliniques Universitaires Saint-Luc — Brussels, Belgium
• Istituto Clinico Humanitas — Milan, Italy
• University Medical Center Utrecht — Utrecht, Netherlands
• St. Mark's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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