RECRUITING

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

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Conditions

Small Bowel DiseaseSmall Intestine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-01-15
Study Completion:2025-05-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06111131

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.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willing and able to provide informed consent;
  2. 2. Subject meets the minimal safety criteria for single balloon enteroscopy: ASA Class I, II, or III;11
  3. 3. ≥ 18 years of age to ≤ 90 years of age;
  4. 4. Video capsule endoscopy identified lesions in the middle third of the small bowel;
  5. 5. Willing and able to comply with all study procedures and follow-up.
  1. 1. History of gastric bypass or related procedures;
  2. 2. History of foregut and/or midgut surgery;
  3. 3. Pathology identified by video capsule is in the proximal 1/3 of the bowel;
  4. 4. Pathology identified by video capsule is in the distal 1/3 of the bowel;
  5. 5. Anticoagulant and antiplatelet therapy that cannot be stopped for the enteroscopy;
  6. 6. Capsule endoscopy did not show clear visualization of pathology in the middle small bowel;
  7. 7. Inability to tolerate the investigator's method of sedation that is the standard of care;
  8. 8. Any previous small bowel surgery, or anastomosis, that caused extensive adhesions and/or altered anatomy;
  9. 9. Allergy to any medications or product used in the endoscopic procedure where the severe allergic reaction cannot be prevented with pre-medication;
  10. 10. Pregnancy;
  11. 11. Life expectancy \< six (6) months.

Contacts and Locations

Study Contact

Chris Schultz, BS
CONTACT
9715067552
cschultz@ecr-inc.com

Study Locations (Sites)

Cedars Sinai
Los Angeles, California, 90048
United States
University of Maryland
Baltimore, Maryland, 21201
United States
Johns Hopkins
Baltimore, Maryland, 21205
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States
The Ohio State University
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Aspero Medical, Inc.

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 Registration Dates

Study Start Date2024-01-15
Study Completion Date2025-05-15

Study Record Updates

Study Start Date2024-01-15
Study Completion Date2025-05-15

Terms related to this study

Keywords Provided by Researchers

  • Small Intestine

Additional Relevant MeSH Terms

  • Small Bowel Disease