N/A
N=1,000
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Adenoma · Polyps · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01917513 ↗Enrolled (actual)
1,000
Serious AEs
0.2%
Results posted
Jan 2018
Primary outcome: Primary: Detection Rate of Adenomas and Serrated Lesions — 147; 194 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- G-EYE™ colonoscopy (Device); Standard Colonoscopy (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Smart Medical Systems Ltd.
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection Rate of Adenomas and Serrated Lesions |
147; 194 | — |
| SECONDARY Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events. |
— | — |
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
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)
- Any patient condition deemed too risky for the study by the investigator
- Previous colonic surgery (except for appendectomy)
Data sourced from ClinicalTrials.gov (NCT01917513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.