Colorectal Cancer Clinical Trial
Official title:
Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Verified date | December 2017 |
Source | Smart Medical Systems Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 1000 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev Hospital | Harlev | |
Germany | Universitätsmedizin Johannes Gutenberg University Mainz | Mainz | |
Germany | Universitätsklinikum Tübingen | Tübingen | |
Germany | Helios Dr. Horst Schmidt Kliniken (HSK) | Wiesbaden | |
India | Asian Institute of Gastroenterology | Hyderabad | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Laniado Hospital | Netanya | |
Israel | Assaf Harofeh Medical Center | Tzrifin | |
Italy | Vita Salute San Raffaele University - Scientific Institute San Raffaele | Milan | |
Netherlands | Maastricht University Medical Centre | Maastricht | |
Netherlands | Radboud UMC | Nijmegen | |
United Kingdom | Birmingham City University | Birmingham | |
United Kingdom | Russells Hall Hospital | Dudley | |
United States | Beth Israel Deaconess Medical Center, Harvard Medical School | Boston | Massachusetts |
United States | NYU Langone Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Smart Medical Systems Ltd. |
United States, Denmark, Germany, India, Israel, Italy, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection Rate of Adenomas and Serrated Lesions | The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group | Approximalty following 14 days (histology results) | |
Secondary | Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events. | The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm | Up to 14 days (histology results) |
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