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

Description

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

Conditions

Small Bowel Disease

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Small Bowel Disease
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars Sinai, Los Angeles, California, United States, 90048

Baltimore

University of Maryland, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins, Baltimore, Maryland, United States, 21205

Saint Louis

Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States, 63110

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Aspero Medical, Inc.,

Study Record Dates

2025-05-15