Clinical trial NCT06111131: Ancora-SB Overtube Complete Positioning and Optical Visualization During Endoscopic Procedures
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Bowel Disease
Keywords: Small Intestine
Lead sponsor: Aspero Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-11-01
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device Superiority
timeFrame: Enteroscopy Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: