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

April 18, 2024 updated by: Aspero Medical, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21205
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine in St. Louis
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ancora-SB Overtube
Enteroscopy with Ancora-SB Balloon Overtube
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.
Active Comparator: Olympus ST-SB1 Overtube
Enteroscopy with Olympus ST-SB1 Overtube
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Superiority
Time Frame: Enteroscopy Procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aspero Medical, Inc.

Collaborators

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

May 15, 2025

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASPE-CLIN-2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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