Third Eye Retroscope Randomized Clinical Evaluation

Colonoscopy is generally agreed to be the best method for detecting and removing
pre-cancerous polyps, but some lesions can be missed, especially if they are located behind
folds in the lining of the colon or behind flexures (sharp bends) in the colon.

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. Previous studies have shown the device
to be effective for detecting additional polyps that could not have been seen with the
colonoscope alone.

The purpose of this research is to compare the additional diagnostic yield obtained by using
the Third Eye® Retroscope® vs. the diagnostic yield for the standard colonoscope alone in
the context of a randomized, controlled study design.

Patients who are scheduled for colonoscopy will be recruited to the study and randomized to
one of two groups. Each patient will undergo two "back-to-back" procedures.

Patients in Group A (study group) will undergo a standard colonoscopy followed immediately
by a Third Eye colonoscopy.

Patients in Group B (control group) will undergo a Third Eye colonoscopy followed
immediately by a standard colonoscopy.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.