Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy
N/A
N/A
Both
Colorectal Neoplasia
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
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.
Type of Study:
Interventional
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:
No
Principal Investigator
Daniel C DeMarco, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor Health Care System
Authority:
United States: Institutional Review Board
Study ID:
Avantis TER 08-07
NCT ID:
NCT00969124
Start Date:
January 2009
Completion Date:
October 2009
Related Keywords:
- Colorectal Neoplasia
- colonoscopy
- polyps
- adenomas
- miss rates
- Neoplasms
Name | Location |
|---|---|
| Baylor University Medical Center | Dallas, Texas 75246 |
| Hennepin County Medical Center | Minneapolis, Minnesota |
| University of Chicago | Chicago, Illinois 60637 |
| Florida Hospital | Orlando, Florida 32803 |
| University of Massachusetts | Worcester, Massachusetts 01655 |
| Parkland Hospital | Dallas, Texas 75390 |
| NorthShore University HealthSystem | Evanston, Illinois |
| S.W. Fort Worth Endoscopy Center | Fort Worth, Texas 76132 |
| North Hills Hospital | North Richland Hills, Texas 76180 |
