Impact of Experience on Results With the Third Eye Retroscope

Not Applicable

Completed

Conditions: Colorectal Neoplasms

Registration Number: NCT00969124

Lead Sponsor: Avantis Medical Systems

Brief Summary: The Third Eye Retroscope is a device that can be used with a colonoscope to improve the ability of a physician to see areas of the colon that may be hidden from the view of the colonoscope.

Previous studies have shown that physicians are able to detect additional polyps when they use the device along with the colonoscope. The purpose of this study is to determine whether physicians can detect greater numbers of additional polyps as they gain in experience with the device.

Detailed Description: Purpose: This study is intended to determine characteristics of the "learning curve" for use of the Third Eye Retroscope during colonoscopy, both in terms of efficacy for detection of abnormalities in the colon and time-efficiency for endoscopists

Device Description: The Third Eye Retroscope is an auxiliary imaging device that is designed to allow visualization of "hidden areas" during colonoscopy by providing an additional, retrograde view that complements the forward view of the colonoscope.

After a standard colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As it emerges from the distal tip of the colonoscope, the Third Eye Retroscope automatically bends 180 degrees to form a "J" shape. Its sensor then provides a continuous retrograde view of the colon throughout the process of withdrawal of the colonoscope.

The retrograde view assists the endoscopist in visualizing the proximal aspect of haustral folds and rectal valves, as well as the areas behind flexures and the ileocecal valve. With this additional point-of-view, the endoscopist may be able to detect lesions that can be missed by the forward-viewing colonoscope.

Study Design: Patients who are scheduled for colonoscopy will be recruited to the study and examined with the Third Eye Retroscope in conjunction with a standard colonoscope. For each polyp that is found, the endoscopist will indicate whether it could be seen with the colonoscope, or if it could be found with the colonoscope only because it was first detected with the Third Eye.

Each investigator will perform colonoscopies on 20 patients, who will be segmented into four quartiles according to the order of their procedures. Mean results for the quartiles will be compared in order to evaluate the learning curve for Third Eye colonoscopy.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 328

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Detection Rates for Adenomas	During the colonoscopy procedure (up to 1 hour, average 25 minutes)	Adenomas detected with the colonoscope alone vs. with the Retroscope
Detection Rates for All Polyps	During the colonoscopy procedure (up to 1 hour, average 25 minutes)	All polyps detected with the colonoscope alone vs. with the Retroscope

Secondary Outcome Measures

Name	Time	Method
Time Spent During Withdrawal Phase and Total Procedure	During the colonoscopy procedure (up to 1 hour, average 25 minutes)	Time in minutes for withdrawal phase of procedure and for total procedure

Trial Locations

Locations (9): Florida Hospital
🇺🇸
Celebration, Florida, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
NorthShore University HealthSystem
🇺🇸
Evanston, Illinois, United States
University of Massachusetts
🇺🇸
Worcester, Massachusetts, United States
Hennepin County Medical Center
🇺🇸
Minneapolis, Minnesota, United States
Parkland Hospital
🇺🇸
Dallas, Texas, United States
Baylor University Medical Center
🇺🇸
Dallas, Texas, United States
S.W. Fort Worth Endoscopy Center
🇺🇸
Fort Worth, Texas, United States
North Hills Hospital
🇺🇸
North Richland Hills, Texas, United States
Florida Hospital
🇺🇸Celebration, Florida, United States