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Impact of Experience on Results With the Third Eye Retroscope

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Third Eye Retroscope
Sponsored by
Avantis Medical Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring colonoscopy, polyps, adenomas, miss rates

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Florida Hospital
  • University of Chicago
  • NorthShore University HealthSystem
  • University of Massachusetts
  • Hennepin County Medical Center
  • Parkland Hospital
  • Baylor University Medical Center
  • S.W. Fort Worth Endoscopy Center
  • North Hills Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Third Eye Retroscope

Arm Description

All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.

Outcomes

Primary Outcome Measures

Detection Rates for Adenomas
Adenomas detected with the colonoscope alone vs. with the Retroscope
Detection Rates for All Polyps
All polyps detected with the colonoscope alone vs. with the Retroscope

Secondary Outcome Measures

Time Spent During Withdrawal Phase and Total Procedure
Time in minutes for withdrawal phase of procedure and for total procedure

Full Information

First Posted
August 27, 2009
Last Updated
June 26, 2017
Sponsor
Avantis Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT00969124
Brief Title
Impact of Experience on Results With the Third Eye Retroscope
Official Title
Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avantis Medical Systems

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
colonoscopy, polyps, adenomas, miss rates

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Third Eye Retroscope
Arm Type
Experimental
Arm Description
All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Intervention Type
Device
Intervention Name(s)
Third Eye Retroscope
Intervention Description
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy
Primary Outcome Measure Information:
Title
Detection Rates for Adenomas
Description
Adenomas detected with the colonoscope alone vs. with the Retroscope
Time Frame
During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Title
Detection Rates for All Polyps
Description
All polyps detected with the colonoscope alone vs. with the Retroscope
Time Frame
During the colonoscopy procedure (up to 1 hour, average 25 minutes)
Secondary Outcome Measure Information:
Title
Time Spent During Withdrawal Phase and Total Procedure
Description
Time in minutes for withdrawal phase of procedure and for total procedure
Time Frame
During the colonoscopy procedure (up to 1 hour, average 25 minutes)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C DeMarco, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
S.W. Fort Worth Endoscopy Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76132
Country
United States
Facility Name
North Hills Hospital
City
North Richland Hills
State/Province
Texas
ZIP/Postal Code
76180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20189513
Citation
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 withdrawal times during colonoscopy: the Third Eye Retroscope study group. Gastrointest Endosc. 2010 Mar;71(3):542-50. doi: 10.1016/j.gie.2009.12.021.
Results Reference
result

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Impact of Experience on Results With the Third Eye Retroscope

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