Back to resultsG-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist
Primary Purpose
Colorectal Cancer, Adenoma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Standard Colonoscopy
G-EYE(TM) Colonoscopy
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Cancer, Adenoma, Standard Colonoscopy, G-EYE(TM) Colonoscopy
Eligibility Criteria
Inclusion Criteria:
- Patients over 50 years old
- Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
- The patient must understand and provide written consent for the procedure.
Exclusion Criteria:
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
- Subjects with diverticulitis or toxic megacolon;
- Subjects with a history of radiation therapy to abdomen or pelvis;
- Pregnant or lactating female subjects;
- Subjects who are currently enrolled in another clinical investigation.
- Subjects with current oral or parenteral use of anticoagulants
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
Sites / Locations
- St. Marienkrankenhaus Frankfurt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy
Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy
Outcomes
Primary Outcome Measures
G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.
Secondary Outcome Measures
polyp and adenoma detection, procedure times and safety
Full Information
NCT ID
NCT02066064
First Posted
February 10, 2014
Last Updated
February 11, 2016
Sponsor
Smart Medical Systems Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02066064
Brief Title
G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist
Official Title
G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate - Randomized Tandem Study With Different Endoscopist
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smart Medical Systems Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy.
Detailed Description
Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Adenoma
Keywords
Colorectal Cancer, Adenoma, Standard Colonoscopy, G-EYE(TM) Colonoscopy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Standard Colonoscopy
Intervention Description
Standard Colonoscopy
Intervention Type
Procedure
Intervention Name(s)
G-EYE(TM) Colonoscopy
Intervention Description
G-EYE(TM) Colonoscopy
Primary Outcome Measure Information:
Title
G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.
Time Frame
estimated 14 days (following histology results)
Secondary Outcome Measure Information:
Title
polyp and adenoma detection, procedure times and safety
Time Frame
24-72 hours post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients over 50 years old
Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
The patient must understand and provide written consent for the procedure.
Exclusion Criteria:
Subjects with inflammatory bowel disease;
Subjects with a personal history of polyposis syndrome;
Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
Subjects with diverticulitis or toxic megacolon;
Subjects with a history of radiation therapy to abdomen or pelvis;
Pregnant or lactating female subjects;
Subjects who are currently enrolled in another clinical investigation.
Subjects with current oral or parenteral use of anticoagulants
Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Kiesslich, Prof.
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Marienkrankenhaus Frankfurt
City
Frankfurt
ZIP/Postal Code
60318
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist
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