An interventional study of G-EYE™ colonoscopy and Standard Colonoscopy in Adenoma, Polyps and Colorectal Cancer, sponsored by Smart Medical Systems Ltd.. Completed at 15 sites in 8 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Smart Medical Systems Ltd. · Not applicable, Interventional, and Diagnostic
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
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 1,000 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Smart Medical Systems Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
G-EYE™ colonoscopy
Device: G-EYE™ colonoscopy
Standard Colonoscopy
Device: Standard Colonoscopy
G-EYE™ colonoscopy
Standard Colonoscopy
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)
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)
| Milestone | Standard Colonoscopy | G-EYE™ Colonoscopy |
|---|---|---|
| Started | 502 | 498 |
| Completed | 407 | 396 |
| Not completed | 95 | 102 |
The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
| Participants | Standard Colonoscopy | G-EYE™ Colonoscopy |
|---|---|---|
| Detection Rate of Adenomas and Serrated Lesions | 147 | 194 |
The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| G-EYE™ Colonoscopy | — | 2/502 (0.4%) | 0/502 (0%) |
| Standard Colonoscopy | — | 0/498 (0%) | 0/498 (0%) |
| Event | G-EYE™ Colonoscopy | Standard Colonoscopy |
|---|---|---|
| obstructive sigmoid tumorGastrointestinal disorders | 1/502 | 0/498 |
| an irregular heart rate and bradycardia prior to the initiation of the procedureCardiac disorders | 1/502 | 0/498 |
| Age, Continuous(years) | Standard Colonoscopy | G-EYE™ Colonoscopy | Total |
|---|---|---|---|
| Mean | 65.2 ± 8.79 | 65.4 ± 8.92 | 65.3 ± 8.85 |
| Sex: Female, Male(Participants) | Standard Colonoscopy | G-EYE™ Colonoscopy | Total |
|---|---|---|---|
| Female | 173 | 204 | 377 |
| Male | 223 | 203 | 426 |
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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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