Colon Cancer Clinical Trial
Official title:
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
Verified date | August 2021 |
Source | GI View Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
Status | Completed |
Enrollment | 79 |
Est. completion date | November 14, 2021 |
Est. primary completion date | August 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy 2. Subject willing to undergo colon preparation bowel cleansing 3. Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60). 4. Subject is able to understand and willing to sign informed consent form Exclusion Criteria: 1. Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC). 2. Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases) 3. Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases) 4. History of colonic resection 5. Clinically significant cardiovascular or pulmonary disease. 6. Cancer or other life threatening disease or significant chronic condition that puts the subject at risk. 7. Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study) 8. Pregnancy 9. Previous radiation therapy to the abdomen 10. Morbid Obesity (BMI > 40 kg/m2) 11. Drug abuse or alcoholism 12. Subject is bed-ridden and/or unable to adequately communicate 13. Subject is under custodial care 14. Subject has a history of psychiatric disorders which would prevent compliance with study instructions 15. Participation in a clinical study within the previous 30 days |
Country | Name | City | State |
---|---|---|---|
Israel | Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
GI View Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aer-O-Scope Validation of Cecal Intubation | The number of subjects for which cecal intubation will be achieved using the Aer-O-Scope Disposable Colonoscope | 30 minutes |
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