Adenoma, Colorectal Cancer, Polyps
Conditions
Keywords
Adenoma, Polyps, CRC, Colonoscopy, Detection Yield
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
This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ high definition colonoscopy vs. the detection rate obtained by performing high definition standard colonoscopy. The study will enroll 1000 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll into this randomized clinical study if the candidate meets the study inclusion and exclusion criteria. Subjects will sign informed consent form and undergo randomization. The study includes a run-in preliminary phase of 270 patients to allow physicians to get familiar with the G-EYE™ endoscope.
Interventions
DEVICEG-EYE™ colonoscopy
G-EYE™ colonoscopy
DEVICEStandard Colonoscopy
Standard Colonoscopy
Sponsors
Smart Medical Systems Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients over 50 years old 2. Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection). 3. The patient must understand and provide written consent for the procedure.
Exclusion criteria
1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with a history of radiation therapy to abdomen or pelvis; 6. Pregnant or lactating female subjects; 7. Subjects who are currently enrolled in another clinical investigation. 8. Subjects with current oral or parenteral use of anticoagulants 9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 10. Any patient condition deemed too risky for the study by the investigator 11. Previous colonic surgery (except for appendectomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Adenomas and Serrated Lesions | Approximalty following 14 days (histology results) | The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events. | Up to 14 days (histology results) | The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm |
Countries
Denmark, Germany, India, Israel, Italy, Netherlands, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Colonoscopy Patients in this group underwent standard high definition colonoscopy | 396 |
| G-EYE™ Colonoscopy Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal | 407 |
| Total | 803 |
Baseline characteristics
| Characteristic | Standard Colonoscopy | G-EYE™ Colonoscopy | Total |
|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 8.79 | 65.4 years STANDARD_DEVIATION 8.92 | 65.3 years STANDARD_DEVIATION 8.85 |
| Sex: Female, Male Female | 173 Participants | 204 Participants | 377 Participants |
| Sex: Female, Male Male | 223 Participants | 203 Participants | 426 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 502 | 0 / 498 |
| serious Total, serious adverse events | 2 / 502 | 0 / 498 |
Outcome results
Primary
Detection Rate of Adenomas and Serrated Lesions
The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
Time frame: Approximalty following 14 days (histology results)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Colonoscopy | Detection Rate of Adenomas and Serrated Lesions | 147 Participants |
| G-EYE™ Colonoscopy | Detection Rate of Adenomas and Serrated Lesions | 194 Participants |
Secondary
Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.
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)