Third Eye Retroscope Randomized Clinical Evaluation (TERRACE)

Tracking Information
First Submitted Date ICMJE	January 6, 2010
First Posted Date ICMJE	January 8, 2010
Results First Submitted Date	August 28, 2015
Results First Posted Date	October 1, 2015
Last Update Posted Date	July 25, 2017
Study Start Date ICMJE	March 2009
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 13, 2016)	Detection Rates for Adenomas and for Total Polyps [ Time Frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes. ]; Numbers of polyps and adenomas detected in first and second procedures for each group
Original Primary Outcome Measures ICMJE; (submitted: January 6, 2010)	Detection Rates for Adenomas and for Total Polyps [ Time Frame: Acute - during procedure ]
Change History	Complete list of historical versions of study NCT01044732 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 13, 2016)	Times for Withdrawal Phase and for Complete Procedure [ Time Frame: Acute - subjects were followed for the duration of the procedures, an average of 40 minutes. ]; For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure
Original Secondary Outcome Measures ICMJE; (submitted: January 6, 2010)	Times for withdrawal phase and for complete colonoscopy procedure [ Time Frame: Acute - during procedure ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Third Eye Retroscope Randomized Clinical Evaluation
Official Title ICMJE	Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)
Brief Summary	The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone. Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first. Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.
Detailed Description	Colonoscopy is generally agreed to be the best method for detecting and removing pre-cancerous polyps, but some lesions can be missed, especially if they are located behind folds in the lining of the colon or behind flexures (sharp bends) in the colon. The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon. Previous studies have shown the device to be effective for detecting additional polyps that could not have been seen with the colonoscope alone. The purpose of this research is to compare the additional diagnostic yield obtained by using the Third Eye® Retroscope® vs. the diagnostic yield for the standard colonoscope alone in the context of a randomized, controlled study design. Patients who are scheduled for colonoscopy will be recruited to the study and randomized to one of two groups. Each patient will undergo two "back-to-back" procedures. Patients in Group A (study group) will undergo a standard colonoscopy followed immediately by a Third Eye colonoscopy. Patients in Group B (control group) will undergo a Third Eye colonoscopy followed immediately by a standard colonoscopy. Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Masking Description: Open Label Primary Purpose: Diagnostic
Condition ICMJE	Colorectal Neoplasms
Intervention ICMJE	Device: Third Eye Retroscope; Device used with colonoscope to provide second, retrograde view of the colon
Study Arms	Experimental: Group A - COLO, then TER Complete examination with standard colonoscope ("COLO") followed by complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope Intervention: Device: Third Eye Retroscope; Active Comparator: Group B - TER, then COLO Complete examination with Third Eye Retroscope ("TER") used in conjunction with standard colonoscope, followed by complete examination with standard colonoscope ("COLO") alone Intervention: Device: Third Eye Retroscope
Publications *	Leufkens AM, DeMarco DC, Rastogi A, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, Siersema PD; Third Eye Retroscope Randomized Clinical Evaluation [TERRACE] Study Group. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc. 2011 Mar;73(3):480-9. doi: 10.1016/j.gie.2010.09.004. Epub 2010 Nov 10.; Siersema PD, Rastogi A, Leufkens AM, Akerman PA, Azzouzi K, Rothstein RI, Vleggaar FP, Repici A, Rando G, Okolo PI, Dewit O, Ignjatovic A, Odstrcil E, East J, Deprez PH, Saunders BP, Kalloo AN, Creel B, Singh V, Lennon AM, DeMarco DC. Retrograde-viewing device improves adenoma detection rate in colonoscopies for surveillance and diagnostic workup. World J Gastroenterol. 2012 Jul 14;18(26):3400-8. doi: 10.3748/wjg.v18.i26.3400.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 22, 2013)	448
Original Estimated Enrollment ICMJE; (submitted: January 6, 2010)	410
Actual Study Completion Date	February 2010
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Italy, Netherlands, United Kingdom, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01044732
Other Study ID Numbers ICMJE	Avantis TER-08-06
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No Plan Description: Aggregated, de-identified data to be published in peer-reviewed medical journal
Responsible Party	Avantis Medical Systems
Study Sponsor ICMJE	Avantis Medical Systems
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Peter D. Siersema, MD, PhD UMC Utrecht
PRS Account	Avantis Medical Systems
Verification Date	June 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP