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

NCT06111131 | Recruiting FDA Device

• 1 other identifier: ASPE-CLIN-2022-01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Small Bowel Disease

Keywords

Small Intestine

Outcome Measures

Primary Outcomes (1)

• Device Superiority

  Demonstrate superiority of the Aspero Medical Ancora-SB balloon Overtube compared to the Olympus ST-SB1 Balloon Overtube. Superiority of the Ancora-SB Balloon Overtube will be demonstrated if it achieves a success rate of ≥75% compared to a success rate of 50% with the Olympus ST-SB1 Balloon Overtube.

  Enteroscopy Procedure

Study Arms (2)

Ancora-SB Overtube

ACTIVE COMPARATOR

Enteroscopy with Ancora-SB Balloon Overtube

Device: Enteroscopy

Olympus ST-SB1 Overtube

ACTIVE COMPARATOR

Enteroscopy with Olympus ST-SB1 Overtube

Device: Enteroscopy

Interventions

Enteroscopy DEVICE

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.

Ancora-SB Overtube; Olympus ST-SB1 Overtube

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent;
• Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
• ≥ 18 years of age to ≤ 90 years of age;
• Video capsule endoscopy identified lesions in the middle third of the small bowel;
• Willing and able to comply with all study procedures and follow-up.

You may not qualify if:

• History of gastric bypass or related procedures;
• History of foregut and/or midgut surgery;
• Pathology identified by video capsule is in the proximal 1/3 of the bowel;
• Pathology identified by video capsule is in the distal 1/3 of the bowel;
• Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy;
• Capsule endoscopy did not show clear visualization of pathology in the middle small bowel;
• Inability to tolerate the investigator's method of sedation that is the standard of care;
• Any previous small bowel surgery, or anastomosis, that caused extensive adhesions and/or altered anatomy;
• Allergy to any medications or product used in the endoscopic procedure where the severe allergic reaction cannot be prevented with pre-medication;
• Pregnancy;
• Life expectancy \< six (6) months.

Sponsors & Collaborators

• Aspero Medical, Inc.: lead
• National Institutes of Health (NIH): collaborator

Study Sites (5)

Cedars Sinai

Los Angeles, California, 90048, United States

NOT YET RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

NOT YET RECRUITING

Johns Hopkins

Baltimore, Maryland, 21205, United States

NOT YET RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Central Study Contacts

Chris Schultz, BS

CONTACT

9715067552; cschultz@ecr-inc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a double-blind randomized 1:1 controlled post-market study; the investigator and the subject will be blind to the device. A qualified staff member will assist the endoscopist by performing the preparation, insertion, and removal of the device the subject was randomized to, to ensure the investigator is blinded. The shaft and handle end of the Ancora-SB overtube will be the same as the Olympus ST-SB1 overtube.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: January 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: May 15, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)