Back to resultsProspective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
Primary Purpose
Adenoma, Polyps, Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
G-EYE™ Colonoscopy
Standard Colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Adenoma focused on measuring Adenoma, Polyp, CRC, Colonoscopy, Detection Yield
Eligibility Criteria
Inclusion Criteria:
- Patients over 50 years old
- Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits, for diagnostic evaluation 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 that have not stopped using anticoagulants as required by the guidelines of the medical center;
- Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
- Any patient condition deemed too risky for the study by the investigator
- Previous colonic surgery (except for appendectomy)
Sites / Locations
- Bnai Zion HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
G-EYE™ Colonoscopy
Standard Colonoscopy
Arm Description
G-EYE™ Colonoscopy
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
The secondary outcome is a composite- each of the measured parameters will be reported as a single value for each arm.
Procedure times
Safety (number of patients with adverse events)
Full Information
NCT ID
NCT02545699
First Posted
August 31, 2015
Last Updated
June 5, 2016
Sponsor
Smart Medical Systems Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02545699
Brief Title
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
Official Title
Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
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 (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.
Detailed Description
This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy.
The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.
Subjects will sign an informed consent form and undergo randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Polyps, Colorectal Cancer
Keywords
Adenoma, Polyp, CRC, Colonoscopy, Detection Yield
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
G-EYE™ Colonoscopy
Arm Type
Experimental
Arm Description
G-EYE™ Colonoscopy
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Standard Colonoscopy
Intervention Type
Device
Intervention Name(s)
G-EYE™ Colonoscopy
Intervention Description
G-EYE™ Colonoscopy
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
Standard 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
Approximately following 14 days (histology results)
Secondary Outcome Measure Information:
Title
Polyp and adenoma detection
Description
The secondary outcome is a composite- each of the measured parameters will be reported as a single value for each arm.
Time Frame
Up to 14 days (Histology results)
Title
Procedure times
Time Frame
At time of procedure
Title
Safety (number of patients with adverse events)
Time Frame
48-72 hours
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, for diagnostic evaluation 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 that have not stopped using anticoagulants as required by the guidelines of the medical center;
Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
Any patient condition deemed too risky for the study by the investigator
Previous colonic surgery (except for appendectomy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tova Rainis, Dr.
Phone
04-8359426
Email
tovarainis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tova Rainis, Dr.
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Hospital
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tova Rainis
First Name & Middle Initial & Last Name & Degree
Tova Rainis
12. IPD Sharing Statement
Learn more about this trial
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
We'll reach out to this number within 24 hrs