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

Not Applicable

Completed

• Conditions: Rectal Cancer; Colon Cancer
• Interventions: Device: Aer-O-Scope Colonoscopy

• Registration Number: NCT00867724
• Lead Sponsor: GI View Ltd.

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.

Study Timeline

• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Study Start: 2009-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-30
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aer-O-Scope Colonoscopy	Aer-O-Scope Colonoscopy	Screening Colonoscopy

Primary Outcome Measures

Name	Time	Method
Ability to screen the entire length of the colon to the cecum.	30 -60 minutes

Secondary Outcome Measures

Name	Time	Method
Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events	24 hours

Trial Locations

Locations (1)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel