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Third Eye Retroscope Randomized Clinical Evaluation (TERRACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avantis Medical Systems
ClinicalTrials.gov Identifier:
NCT01044732
First received: January 6, 2010
Last updated: July 13, 2016
Last verified: July 2016

January 6, 2010
July 13, 2016
March 2009
February 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Numbers of polyps and adenomas detected in first and second procedures for each group
Detection Rates for Adenomas and for Total Polyps [ Time Frame: Acute - during procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01044732 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
For all examinations with each method (SC or TEC), mean time for withdrawal phase and mean time for total procedure
Times for withdrawal phase and for complete colonoscopy procedure [ Time Frame: Acute - during procedure ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Third Eye Retroscope Randomized Clinical Evaluation
Third Eye Retroscope Randomized Clinical Evaluation (The "TERRACE" Study)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Colorectal Neoplasms
Device: Third Eye Retroscope
Device used with colonoscope to provide second, retrograde view of the colon
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
448
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Italy,   Netherlands,   United Kingdom
 
NCT01044732
Avantis TER-08-06
No
Not Provided
Not Provided
Avantis Medical Systems
Avantis Medical Systems
Not Provided
Principal Investigator: Peter D. Siersema, MD, PhD UMC Utrecht
Avantis Medical Systems
July 2016

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