Impact of Experience on Results With the Third Eye Retroscope

Colorectal Neoplasia Clinical Trial

Official title:

Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969124
• Other study ID #: Avantis TER 08-07
• Status: Completed
• Phase: N/A
• First received: August 27, 2009
• Last updated: January 22, 2013
• Start date: January 2009
• Est. completion date: October 2009

Study information

• Verified date: January 2013
• Source: Avantis Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;

2. The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

1. Patients with a history of colonic resection;

2. Patients with inflammatory bowel disease;

3. Patients with a personal history of polyposis syndrome;

4. Patients with suspected chronic stricture potentially precluding complete colonoscopy;

5. Patients with diverticulitis or toxic megacolon;

6. Patients with a history of radiation therapy to abdomen or pelvis.

7. 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasia

Intervention

Device:
• Third Eye Retroscope
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy

Locations

Country	Name	City	State
United States	Florida Hospital	Celebration	Florida
United States	University of Chicago	Chicago	Illinois
United States	Baylor University Medical Center	Dallas	Texas
United States	Parkland Hospital	Dallas	Texas
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	S.W. Fort Worth Endoscopy Center	Fort Worth	Texas
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	North Hills Hospital	North Richland Hills	Texas
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Avantis Medical Systems

Country where clinical trial is conducted

United States, 

References & Publications (1)

DeMarco DC, Odstrcil E, Lara LF, Bass D, Herdman C, Kinney T, Gupta K, Wolf L, Dewar T, Deas TM, Mehta MK, Anwer MB, Pellish R, Hamilton JK, Polter D, Reddy KG, Hanan I. Impact of experience with a retrograde-viewing device on adenoma detection rates and — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rates for adenomas and for all polyps by the Third Eye Retroscope in comparison to the standard colonoscope alone		The study is an acute study only. The utility of the device will be assessed from immediate (peri-procedural) clinical outcomes of patients enrolled into the study and from 24-72 hour telephone follow-up to assess for post-procedural complications.	No
Secondary	Time spent during the withdrawal phase and total procedure time for colonoscopy using the Third Eye Retroscope		The study is an acute study only. The duration of procedural time intervals will be determined during the procedures performed on study patients.	No