Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures

Launched by ASPERO MEDICAL, INC. · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called the Ancora-SB balloon Overtube, which is used during endoscopic procedures to examine the small intestine. The goal is to see if this new device works better than an existing one, the Olympus ST-SB1 Balloon Overtube, for helping doctors find and treat problems in the small bowel. The trial is currently looking for participants aged 18 to 90 who have had specific types of lesions identified in the middle part of their small intestine through a video capsule endoscopy—a test that uses a tiny camera to take pictures of the digestive tract.

To be eligible for this study, participants should be in generally good health and able to give consent to join the trial. However, individuals with certain medical histories, like previous stomach surgeries or those who cannot stop certain medications, may not be able to participate. If you decide to join, you can expect to undergo procedures with close monitoring and follow-up. This trial is a great opportunity for those with small bowel disease to potentially benefit from a new approach to treatment while contributing to important medical research.

Gender

ALL

Eligibility criteria

• 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.