Status:
RECRUITING
Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures
Lead Sponsor:
Aspero Medical, Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Small Bowel Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
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 expect...
Eligibility Criteria
Inclusion
- Willing and able to provide informed consent;
- Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
- ≥ 18 years of age to ≤ 90 years of age;
- Video capsule endoscopy identified lesions in the middle third of the small bowel;
- Willing and able to comply with all study procedures and follow-up.
Exclusion
- History of gastric bypass or related procedures;
- History of foregut and/or midgut surgery;
- Pathology identified by video capsule is in the proximal 1/3 of the bowel;
- Pathology identified by video capsule is in the distal 1/3 of the bowel;
- Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy;
- Capsule endoscopy did not show clear visualization of pathology in the middle small bowel;
- Inability to tolerate the investigator's method of sedation that is the standard of care;
- Any previous small bowel surgery, or anastomosis, that caused extensive adhesions and/or altered anatomy;
- Allergy to any medications or product used in the endoscopic procedure where the severe allergic reaction cannot be prevented with pre-medication;
- Pregnancy;
- Life expectancy \< six (6) months.
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2025
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT06111131
Start Date
January 15 2024
End Date
May 15 2025
Last Update
April 19 2024
Active Locations (5)
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1
Cedars Sinai
Los Angeles, California, United States, 90048
2
University of Maryland
Baltimore, Maryland, United States, 21201
3
Johns Hopkins
Baltimore, Maryland, United States, 21205
4
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110