Colorectal Cancer Clinical Trial
Official title:
Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy
The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.
Status | Recruiting |
Enrollment | 350 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
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, for diagnostic evaluation 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 that have not stopped using anticoagulants as required by the guidelines of the medical center; 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | Bnai Zion Hospital | Haifa |
Lead Sponsor | Collaborator |
---|---|
Smart Medical Systems Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | G-EYE™ Colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same | Approximately following 14 days (histology results) | No | |
Secondary | Polyp and adenoma detection | 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) | No |
Secondary | Procedure times | At time of procedure | No | |
Secondary | Safety (number of patients with adverse events) | 48-72 hours | Yes |
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