Small Bowel Disease Clinical Trial
Official title:
A Randomized Controlled Trial to Demonstrate the Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures for Diagnosis and Treatment in the Small Intestine
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.
Status | Recruiting |
Enrollment | 123 |
Est. completion date | May 15, 2025 |
Est. primary completion date | March 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 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; 5. Willing and able to comply with all study procedures and follow-up. Exclusion Criteria: 1. History of gastric bypass or related procedures; 2. History of foregut and/or midgut surgery; 3. Pathology identified by video capsule is in the proximal 1/3 of the bowel; 4. Pathology identified by video capsule is in the distal 1/3 of the bowel; 5. Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy; 6. Capsule endoscopy did not show clear visualization of pathology in the middle small bowel; 7. Inability to tolerate the investigator's method of sedation that is the standard of care; 8. Any previous small bowel surgery, or anastomosis, that caused extensive adhesions and/or altered anatomy; 9. Allergy to any medications or product used in the endoscopic procedure where the severe allergic reaction cannot be prevented with pre-medication; 10. Pregnancy; 11. Life expectancy < six (6) months. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
United States | University of Maryland | Baltimore | Maryland |
United States | The Ohio State University | Columbus | Ohio |
United States | Cedars Sinai | Los Angeles | California |
United States | Washington University School of Medicine in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Aspero Medical, Inc. | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device Superiority | Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube. Superiority of the Ancora-SB Balloon Overtube will be demonstrated if it achieves a success rate of =75% compared to a success rate of 50% with the Olympus ST-SB1 Balloon Overtube. | Enteroscopy Procedure |
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