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

Not Enrolling
Colorectal Neoplasia

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Trial Information

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

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.

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Detection rates for adenomas and for all polyps by the Third Eye Retroscope in comparison to the standard colonoscope alone

Outcome Time Frame:

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.

Safety Issue:


Principal Investigator

Daniel C DeMarco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Health Care System


United States: Institutional Review Board

Study ID:

Avantis TER 08-07



Start Date:

January 2009

Completion Date:

October 2009

Related Keywords:

  • Colorectal Neoplasia
  • colonoscopy
  • polyps
  • adenomas
  • miss rates
  • Neoplasms



Baylor University Medical CenterDallas, Texas  75246
Hennepin County Medical CenterMinneapolis, Minnesota  
University of ChicagoChicago, Illinois  60637
Florida HospitalOrlando, Florida  32803
University of MassachusettsWorcester, Massachusetts  01655
Parkland HospitalDallas, Texas  75390
NorthShore University HealthSystemEvanston, Illinois  
S.W. Fort Worth Endoscopy CenterFort Worth, Texas  76132
North Hills HospitalNorth Richland Hills, Texas  76180