Impact of Experience on Results With the Third Eye Retroscope

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avantis Medical Systems
ClinicalTrials.gov Identifier:
NCT00969124
First received: August 27, 2009
Last updated: January 22, 2013
Last verified: January 2013

August 27, 2009
January 22, 2013
January 2009
October 2009   (final data collection date for primary outcome measure)
Detection rates for adenomas and for all polyps by the Third Eye Retroscope in comparison to the standard colonoscope alone [ 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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00969124 on ClinicalTrials.gov Archive Site
Time spent during the withdrawal phase and total procedure time for colonoscopy using the Third Eye Retroscope [ Time Frame: The study is an acute study only. The duration of procedural time intervals will be determined during the procedures performed on study patients. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Experience on Results With the Third Eye Retroscope
Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Colorectal Neoplasia
Device: Third Eye Retroscope
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy
Experimental: Third Eye Retroscope
Intervention: Device: Third Eye Retroscope
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
328
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00969124
Avantis TER 08-07
No
Avantis Medical Systems
Avantis Medical Systems
Not Provided
Principal Investigator: Daniel C DeMarco, MD Baylor Health Care System
Avantis Medical Systems
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP