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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00867724

Enrollment

Registered

2009-03-24

Start date

2009-09-30

Completion date

2013-07-31

Last updated

2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Rectal Cancer

Keywords

polyp

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.

Interventions

DEVICEAer-O-Scope Colonoscopy

Screening Colonoscopy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Ability to screen the entire length of the colon to the cecum.	30 -60 minutes

Secondary

Measure	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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026