Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients

GI View

Status

Completed

Conditions

Colon Cancer

Rectal Cancer

Treatments

Device: Aer-O-Scope Colonoscopy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00867724

190-CLD-AOS

Details and patient eligibility

About

A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.

Full description

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.

Enrollment

68 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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).
Pregnant women
Patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure
Morbid Obesity (BMI > 40)
Drug abuse or alcoholism
Bed-ridden patient
Inadequate communication with the patient
Patients under custodial care
Participation in current clinical study or clinical study within 30 days prior to the procedure