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

Small Bowel Disease Clinical Trial

Official title:
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

Clinical Trial Summary

Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06111131
Study type Interventional
Source Aspero Medical, Inc.
Contact Chris Schultz, BS
Phone 9715067552
Email cschultz@ecr-inc.com
Status Recruiting
Phase N/A
Start date January 15, 2024
Completion date May 15, 2025
View Details
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