Comparison of two balloon overtubes for small bowel procedures

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

This study is testing whether a new type of balloon overtube can help doctors find problems in the small intestine more effectively during procedures compared to an older version.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 123 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Aspero Medical, Inc. (Industry-sponsored)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT06111131 on ClinicalTrials.gov

What this trial studies

This study aims to demonstrate the superiority of the Aspero Medical Ancora-SB balloon overtube over the Olympus ST-SB1 Balloon Overtube during endoscopic procedures for small bowel disease. Patients scheduled for enteroscopy will be recruited, and video capsule endoscopy will be used to identify lesions in the middle third of the small bowel. The primary outcome is the success rate of identifying these lesions, which indicates effective balloon control for visualization. The goal is to improve procedure success rates and reduce the time to diagnosis or treatment, ultimately enhancing patient outcomes and reducing healthcare costs.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with lesions identified in the middle third of the small bowel via video capsule endoscopy.

Not a fit: Patients with a history of gastric bypass, certain surgical histories, or lesions located in the proximal or distal thirds of the bowel may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and treatment outcomes for patients with small bowel disease.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for successful outcomes.

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.

Where this trial is running

Los Angeles, California and 4 other locations

• Cedars Sinai — Los Angeles, California, United States (Not_yet_recruiting)
• University of Maryland — Baltimore, Maryland, United States (Not_yet_recruiting)
• Johns Hopkins — Baltimore, Maryland, United States (Not_yet_recruiting)
• Washington University School of Medicine in St. Louis — Saint Louis, Missouri, United States (Not_yet_recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Chris Schultz, BS

Conditions Small Bowel Disease; Small Intestine