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Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures | Clinical Trials | Clareo Health

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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

NCT06111131•Aspero Medical, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

Locations (5)

Cedars Sinai

Los Angeles, California, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins

Baltimore, Maryland, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

The Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

January 15, 2024

Primary Completion Date

March 15, 2025

Completion Date

May 15, 2025

Last Updated

April 19, 2024

Enrollment

123

ESTIMATED participants

Conditions

Small Bowel Disease

Interventions

Enteroscopy

DEVICE

Contacts

Chris Schultz, BS

CONTACT

9715067552 cschultz@ecr-inc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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