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

Small Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111131
• Other study ID #: ASPE-CLIN-2022-01
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: April 2024
• Source: Aspero Medical, Inc.
• Contact: Chris Schultz, BS
• Phone: 9715067552
• Email: cschultz[@]ecr-inc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: May 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intestinal Diseases
• Small Bowel Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	The Ohio State University	Columbus	Ohio
United States	Cedars Sinai	Los Angeles	California
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Aspero Medical, Inc.	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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