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

Aspero Medical

Status: Enrolling

Conditions: Small Bowel Disease

Treatments: Device: Enteroscopy

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06111131

ASPE-CLIN-2022-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 123 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups

Ancora-SB Overtube

Active Comparator group

Description:

Enteroscopy with Ancora-SB Balloon Overtube

Treatment:

Device: Enteroscopy

Olympus ST-SB1 Overtube

Active Comparator group

Description:

Enteroscopy with Olympus ST-SB1 Overtube

Treatment:

Device: Enteroscopy