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

This study has been completed.
Information provided by (Responsible Party):
GI View Ltd. Identifier:
First received: March 23, 2009
Last updated: July 30, 2017
Last verified: July 2017
A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.

Condition Intervention
Colon Cancer Rectal Cancer Device: Aer-O-Scope Colonoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: A Clinical Study to Evaluate the Performance & Safety of the "Aer-O-Scope" Traveling Through the Colon in Low Risk Subjects

Resource links provided by NLM:

Further study details as provided by GI View Ltd.:

Primary Outcome Measures:
  • Ability to screen the entire length of the colon to the cecum. [ Time Frame: 30 -60 minutes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 68
Study Start Date: September 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aer-O-Scope Colonoscopy
Screening Colonoscopy
Device: Aer-O-Scope Colonoscopy
Screening Colonoscopy
Other Name: Aer-O-Scope

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00867724

Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
GI View Ltd.
Principal Investigator: Erwin M Santo, MD Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: GI View Ltd. Identifier: NCT00867724     History of Changes
Other Study ID Numbers: 190-CLD-AOS
Study First Received: March 23, 2009
Last Updated: July 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by GI View Ltd.:

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on August 16, 2017