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

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

Detailed 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.

Official Title
-----------------
A Clinical Study to Evaluate the Performance & Safety of the Aer-O-Scope Traveling Through the Colon in Low Risk Subjects

Conditions
-----------------
Colon Cancer, Rectal Cancer

Intervention / Treatment
-----------------
* Device: Aer-O-Scope Colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aer-O-Scope Colonoscopy<br>Screening Colonoscopy | Device: Aer-O-Scope Colonoscopy<br>* Screening Colonoscopy<br>* Other names: Aer-O-Scope;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to screen the entire length of the colon to the cecum. |  | 30 -60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polyp