Third Eye Retroscope Randomized Clinical Evaluation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Third Eye Retroscope Randomized Clinical Evaluation (The TERRACE Study)

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Device: Third Eye Retroscope


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - COLO, then TER<br>Complete examination with standard colonoscope (COLO) followed by complete examination with Third Eye Retroscope (TER) used in conjunction with standard colonoscope | Device: Third Eye Retroscope<br>* Device used with colonoscope to provide second, retrograde view of the colon<br>|
| Active Comparator: Group B - TER, then COLO<br>Complete examination with Third Eye Retroscope (TER) used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope (COLO) alone | Device: Third Eye Retroscope<br>* Device used with colonoscope to provide second, retrograde view of the colon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection Rates for Adenomas and for Total Polyps | Numbers of polyps and adenomas detected in first and second procedures for each group | Acute - subjects were followed for the duration of the procedures, an average of 40 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Times for Withdrawal Phase and for Complete Procedure | For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure | Acute - subjects were followed for the duration of the procedures, an average of 40 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal, Neoplasms, Adenomas, Polyps, Miss rates, Detection rates, Colonoscope, Third Eye Retroscope