Status:
COMPLETED
Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients
Lead Sponsor:
GI View Ltd.
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
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 colonoscop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00867724
Start Date
September 1 2009
End Date
July 1 2013
Last Update
August 1 2017
Active Locations (1)
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1
Sourasky Medical Center
Tel Aviv, Israel