Third Eye Retroscope Randomized Clinical Evaluation (TERRACE)
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ClinicalTrials.gov Identifier: NCT01044732 |
Recruitment Status
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Completed
First Posted
: January 8, 2010
Results First Posted
: October 1, 2015
Last Update Posted
: July 25, 2017
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Tracking Information | |||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
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 |
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
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Original Secondary Outcome Measures ICMJE |
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. |
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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. |
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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 |
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Condition ICMJE | Colorectal Neoplasms | ||||
Intervention ICMJE | Device: Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
448 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | ||||
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 |
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Responsible Party | Avantis Medical Systems | ||||
Study Sponsor ICMJE | Avantis Medical Systems | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |