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Completed

NCT Number: NCT00867724

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aer-O-Scope Colonoscopy

Device

Screening Colonoscopy

Other names: Aer-O-Scope

Primary outcomes

  1. Ability to screen the entire length of the colon to the cecum.

    Time frame: 30 -60 minutes

Secondary outcomes

  1. Safety endpoints to include incidence of bowel perforation, Colonic bleeding, Damage to colon, rectum and anus mucosa or any other Adverse events

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

GI View Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 24, 2009
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.