NCT06111131

Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Aspero Medical, Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Small Bowel Disease

Interventions

Type	Name	Description
DEVICE	Enteroscopy	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.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-03-15
• Completion: 2025-05-15
• First posted: 2023-11-01
• Last updated: 2024-04-19

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study