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Impact of Experience on Results With the Third Eye Retroscope

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00969124
First Posted: September 1, 2009
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avantis Medical Systems
Results First Submitted: July 18, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
Third Eye Retroscope All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.

Participant Flow:   Overall Study
    Third Eye Retroscope
STARTED   328 
COMPLETED   298 
NOT COMPLETED   30 
Protocol Violation                2 
Inadequate bowel preparation                15 
Inability to reach cecum                9 
Previously unrecognized disease                3 
Technical error                1 



  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.
Per-protocol population of patients for whom the colonoscopy procedure was completed using the Third Eye Retroscope, not including the 30 who were withdrawn due to reasons stated above.

Reporting Groups
  Description
Third Eye Retroscope All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.

Baseline Measures
   Third Eye Retroscope 
Overall Participants Analyzed 
[Units: Participants]
 298 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.8  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      154  51.7% 
Male      144  48.3% 
Region of Enrollment 
[Units: Participants]
 
United States   298 
Indication for colonoscopy procedure (screening, surveillance or diagnostic) 
[Units: Participants]
 
Screening   164 
Surveillance   62 
Diagnostic   72 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Detection Rates for Adenomas   [ Time Frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes) ]

2.  Primary:   Detection Rates for All Polyps   [ Time Frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes) ]

3.  Secondary:   Time Spent During Withdrawal Phase and Total Procedure   [ Time Frame: During the colonoscopy procedure (up to 1 hour, average 25 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
No randomization or blinding and no separate control group. Determinations regarding adequacy of bowel cleansing and whether each polyp could have been detected with the colonoscope alone involved a judgement by the endoscopist.


  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 , Inc.
phone: 4086367226
e-mail: jhiggins@avantismedical.com


Publications of Results:

Responsible Party: Avantis Medical Systems
ClinicalTrials.gov Identifier: NCT00969124     History of Changes
Other Study ID Numbers: Avantis TER 08-07
First Submitted: August 27, 2009
First Posted: September 1, 2009
Results First Submitted: July 18, 2016
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017