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

NCT ID: NCT00867724

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-07-31

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.

Conditions

Colon Cancer; Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Aer-O-Scope Colonoscopy

Screening Colonoscopy

Group Type: EXPERIMENTAL

Aer-O-Scope Colonoscopy

Intervention Type: DEVICE

Screening Colonoscopy

Interventions

Aer-O-Scope Colonoscopy

Screening Colonoscopy

Intervention Type: DEVICE

Other Intervention Names

Aer-O-Scope

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GI View Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erwin M Santo, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

190-CLD-AOS

Identifier Type: -

Identifier Source: org_study_id