Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
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A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.
Condition or disease
Colon CancerRectal Cancer
Device: Aer-O-Scope Colonoscopy
Asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patients between 18 and 70 years of age
Patients who are generally healthy and classified as low risk for CRC
Patients who are ready to undergo standard colonoscopy examination including colon prep.
Signed informed consent
Patients with any known GI related symptoms complaints or GI diseases
Patients with cancer or other life threatening diseases or conditions
Patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. Patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (Patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study).
Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
Morbid Obesity (BMI > 40)
Drug abuse or alcoholism
Inadequate communication with the patient
Patients under custodial care
Participation in current clinical study or clinical study within 30 days prior to the procedure