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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Adenoma; Polyps

• Registration Number: NCT01917513
• Lead Sponsor: Smart Medical Systems Ltd.

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.

Study Timeline

• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-08-04
• Study First Posted: 2013-08-06
• Study Start: 2014-05
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-12
• Results First Submitted: 2017-12-18
• Results First Submitted QC: 2017-12-26
• Last Update Submitted: 2017-12-26
• Results First Posted: 2018-01-23
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Beth Israel Deaconess Medical Center, Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

Herlev Hospital; 🇩🇰 Harlev, Denmark

Universitätsmedizin Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Helios Dr. Horst Schmidt Kliniken (HSK); 🇩🇪 Wiesbaden, Germany

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, India

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Laniado Hospital; 🇮🇱 Netanya, Israel

Assaf Harofeh Medical Center; 🇮🇱 Tzrifin, Israel

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