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

Phase 2/Phase 3
18 Years
70 Years
Open (Enrolling)
Colon Cancer, Rectal Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

30 -60 minutes

Safety Issue:


Principal Investigator

Erwin M Santo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tel-Aviv Sourasky Medical Center


Israel: Ministry of Health

Study ID:




Start Date:

September 2009

Completion Date:

March 2012

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • polyp
  • Colonic Neoplasms
  • Rectal Neoplasms