What is the Purpose of this Study?
The purpose of this study is to evaluate the Aspero Medical, Inc. Ancora-SB (single balloon) overtube device as a possible technology for the diagnosis and/or treatment of small bowel diseases. Specifically, researchers aim to determine whether the Ancora-SB overtube is superior in performance to the Olympus ST-SB1 overtube. Performance characteristics that are being assessed include being able to identify the area of interest (target area). Participants will be patients who need to undergo an endoscopic procedure of the small intestine. They will be randomly assigned to 1 of 2 study products, both approved by the U.S. Food and Drug Administration (FDA), to assist with their endoscopy.
Eligibility
- 1. Willing and able to provide informed consent;
- 2. Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
- 3. ≥ 18 years of age to ≤ 90 years of age;
- 4. Video capsule endoscopy identified lesions in the middle third of the small bowel;
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Randomized Controlled Trial to Demonstrate the Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures for Diagnosis and Treatment of Pathologies in the Small Intestine