Third Eye Retroscope Randomized Clinical Evaluation

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.

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Key information

Conditions

Colorectal Neoplasms Adenoma Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Third Eye Retroscope

Device

Device used with colonoscope to provide second, retrograde view of the colon

Primary outcomes

Detection Rates for Adenomas and for Total Polyps

Time frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.

Numbers of polyps and adenomas detected in first and second procedures for each group

Secondary outcomes

Times for Withdrawal Phase and for Complete Procedure

Time frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes.

For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure

Sponsors and collaborators

Lead sponsor

Avantis Medical Systems

Industry

Registry information

Official study title

Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)

Acronym: TERRACE

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jan 8, 2010
Registry last updated: Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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