Post Market Evaluation of Aer-O-Scope Visualization

Stopped early · Not applicable

Conditions studied: Cancer

In brief

This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope System and a conventional colonoscope since this is a tandem colonoscopy study, each subject will serve as their own control. The 1st procedure will be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. The same investigator will perform both procedures on each subject. All pathologies found will be either removed or tattooed. Unmarked pathologies found on second pass will represent those missed during the 1st pass, thus making the subject and the control one and the same. Tattooed pathologies that can be removed endoscopically will be removed in an additional colonoscopy. This may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be removed with conventional colonoscopy.

Key facts

Study ID

NCT02926209

Run by

GI View Ltd.

People needed

104

Starts

2017-02-21

Expected to finish

2018-04-11

Last updated by the study team

2019-07-16

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is indicated for screening, diagnostic (minor complaints such as rectal bleeding or minor abdominal pain) or surveillance colonoscopy
• Subject willing to undergo tandem colonoscopies with Aer-O-Scope Colonoscope and a conventional colonoscope (including a single colon preparation bowel cleansing)
• Subject between the ages of 45 and 75 (patients between the ages of 45 and 50 must have a family history of a first degree relative with onset of colon cancer before the age of 60).
• Subject is able to understand and willing to sign informed consent form

You may not qualify if…

• Personal history of colorectal neoplasia including familial adenomatous polyposis or hereditary nonpolyposis, colon cancer (HNPCC).
• Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative colitis or Crohn's colitis), bowel obstruction, or acute diverticulitis, or known severe diverticulosis, fecal incontinence or any known large-bowel disease that would require a predetermined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
• Severe gastrointestinal tract-related symptoms, or complaints, suggesting performance of a pre-determined therapeutic colonoscopy (non-screening, non-diagnostic or non-surveillance cases)
• History of colonic resection
• Clinically significant cardiovascular or pulmonary disease.
• Cancer or other life threatening disease or significant chronic condition that puts the subject at risk.
• Blood-clotting disorders and/or current anticoagulant therapy (Subjects taking up to 100mg aspirin for prophylactic treatment are acceptable for this study)
• Pregnancy
• Previous radiation therapy to the abdomen
• Morbid Obesity (BMI > 40 kg/m2)
• Drug abuse or alcoholism
• Subject is bed-ridden and/or unable to adequately communicate
• Subject is under custodial care
• Subject has a history of psychiatric disorders which would prevent compliance with study instructions
• Participation in a clinical study within the previous 30 days

Where it is running

• Waldron Endoscopy Center — Tacoma, Washington, United States
• Tel Aviv Souraski Medical Center — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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