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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: August 24, 2016
Last verified: August 2016
Results First Received: August 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Colorectal Neoplasms
Intervention: Device: Third Eye Retroscope

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A - SC Followed by TEC

Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)

Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon

Group B - TEC Followed by SC

Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)

Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon


Participant Flow:   Overall Study
    Group A - SC Followed by TEC   Group B - TEC Followed by SC
STARTED   222   226 
COMPLETED   173   176 
NOT COMPLETED   49   50 
Lost to Follow-up                2                1 
Physician Decision                5                3 
Protocol Violation                11                12 
Withdrawal by Subject                0                1 
Inadequate bowel preparation                11                17 
Inability to reach cecum                5                2 
Technical error or malfunction                15                14 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat population, i.e., those who were actually examined during the study

Reporting Groups
  Description
Group A - SC Followed by TEC

Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)

Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon

Group B - TEC Followed by SC

Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)

Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon

Total Total of all reporting groups

Baseline Measures
   Group A - SC Followed by TEC   Group B - TEC Followed by SC   Total 
Overall Participants Analyzed 
[Units: Participants]
 184   188   372 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (9.8)   58.0  (9.7)   57.8  (9.7) 
Gender 
[Units: Participants]
     
Female   69   59   128 
Male   115   129   244 
Region of Enrollment 
[Units: Participants in ITT population]
     
Netherlands   19   22   41 
Belgium   24   26   50 
United States   114   111   225 
Italy   25   28   53 
United Kingdom   2   1   3 
Indication for colonoscopy procedure 
[Units: Participants in ITT population]
     
Screening   97   92   189 
Surveillance   41   55   96 
Diagnostic   46   41   87 


  Outcome Measures
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1.  Primary:   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. ]

2.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
With mean subject age of 57.8 years, population was younger than in some studies, so polyp prevalence might be below average.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jack Higgins, MD - Chief Medical Officer
Organization: Avantis Medical Systems
phone: 6508239216
e-mail: jhiggins@avantismedical.com


Publications of Results:

Responsible Party: Avantis Medical Systems
ClinicalTrials.gov Identifier: NCT01044732     History of Changes
Other Study ID Numbers: Avantis TER-08-06
Study First Received: January 6, 2010
Results First Received: August 28, 2015
Last Updated: August 24, 2016
Health Authority: United States: Food and Drug Administration