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

Completed · Not applicable

Conditions studied: Adenoma, Polyps, Colorectal Cancer

In brief

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

Key facts

Study ID

NCT01917513

Run by

Smart Medical Systems Ltd.

People needed

1000

Starts

2014-05-01

Expected to finish

2016-09-01

Last updated by the study team

2018-01-23

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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