Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
- Conditions
- Colorectal CancerAdenomaPolyps
- Interventions
- Device: Standard ColonoscopyDevice: G-EYE™ colonoscopy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Colonoscopy Standard Colonoscopy Standard Colonoscopy G-EYE™ colonoscopy G-EYE™ colonoscopy G-EYE™ colonoscopy
- 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)
Herlev Hospital
🇩🇰Harlev, Denmark
Beth Israel Deaconess Medical Center, Harvard Medical School
🇺🇸Boston, Massachusetts, United States
Universitätsmedizin Johannes Gutenberg University Mainz
🇩🇪Mainz, Germany
Helios Dr. Horst Schmidt Kliniken (HSK)
🇩🇪Wiesbaden, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Hadassah Medical Center
🇮🇱Jerusalem, Israel
Assaf Harofeh Medical Center
🇮🇱Tzrifin, Israel
Laniado Hospital
🇮🇱Netanya, Israel
Vita Salute San Raffaele University - Scientific Institute San Raffaele
🇮🇹Milan, Italy
Maastricht University Medical Centre
🇳🇱Maastricht, Netherlands
Radboud UMC
🇳🇱Nijmegen, Netherlands
Birmingham City University
🇬🇧Birmingham, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, United Kingdom
NYU Langone Medical Center
🇺🇸New York, New York, United States
Asian Institute of Gastroenterology
🇮🇳Hyderabad, India