Small Bowel Disease
Conditions
Keywords
Small Intestine
Brief summary
Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.
Detailed description
The study objective, demonstrate superiority of the Aspero Ancora-SB balloon overtube compared to the Olympus ST-SB1 Balloon Overtube, is necessary for adoption by clinicians. Broad adoption is expected to improve procedure success rates, reduce time to diagnosis or treatment (thereby, improving patient outcomes), and reduce the burden and costs of care for patients, providers, and insurers. Investigators propose to recruit patients scheduled for enteroscopy and use capsule endoscopy to identify patients with lesions in the middle third of the small bowel. The primary outcome of interest is success in identifying the lesion, which indicates sufficient balloon control to reach and visualize the site.
Interventions
DEVICEEnteroscopy
A procedure that uses a specially equipped endoscope to examine the small intestine lining. An enteroscopy uses an endoscope, a tube with a light and camera on the end and the endoscope, in the case of this study, is equipped with a single balloon overtube to advance the scope deeper into the small intestine, to reach the middle third of the small bowel.
Sponsors
National Institutes of Health (NIH)
Aspero Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a double-blind randomized 1:1 controlled post-market study; the investigator and the subject will be blind to the device. A qualified staff member will assist the endoscopist by performing the preparation, insertion, and removal of the device the subject was randomized to, to ensure the investigator is blinded. The shaft and handle end of the Ancora-SB overtube will be the same as the Olympus ST-SB1 overtube.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Superiority | Enteroscopy Procedure | 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. |
Countries
United States
Contacts
Primary ContactChris Schultz, BS
Outcome results
None listed