N/A Completed N=1,000 Randomized Diagnostic

Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Adenoma · Polyps · Colorectal Cancer

Source: ClinicalTrials.gov NCT01917513 ↗

Enrolled (actual)

1,000

Serious AEs

0.2%

Results posted

Jan 2018

Primary outcomePrimary: Detection Rate of Adenomas and Serrated Lesions — 147; 194 Participants

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

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.	—	—

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)

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.