Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD

Smart Medical Systems

Status: Unknown

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Device: NaviAid™ AB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02629211

AB 17701

Details and patient eligibility

About

To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.

Full description

In 15%-25% of diagnosed inflammatory bowel disease (IBD) cases, disease manifestation begins before the age of 18. IBD primary includes Crohn's disease (CD) and ulcerative colitis (UC). Studies have shown that the current incidence of pediatric IBD ranges from 4-7 cases per 100,000, worldwide. Early and accurate diagnosis of IBD is important for correct prognosis, course of disease, therapeutic decisions and follow-up. Complete diagnostic work-up is key to proper diagnosis in patients.Early diagnosis of IBD and differentiation between UC and CD can be difficult in children. The major issues that face pediatric IBD today include accurate disease classification, unknown extent of disease, complete bowel visualization, inability to reach depth of findings, and biopsy retrieval for diagnostic work-up.

The NaviAid™ AB device presents a new and unique concept that helps overcome these short comings of IBD diagnosis and treatment. Through repetitive inflation and deflation of the NaviAid™ AB, the endoscope can be swiftly advanced deep into the small bowel via the proximal or distal route, allowing for complete visualization of the small bowel and easy biopsy sampling for histopathology. As a result, subsequent diagnoses can influence proper action for further treatment and therapy for the patient. Although many studies have reported on the safety and efficacy of balloon enteroscopy in adults with IBD, further investigation of the value of balloon enteroscopy in pediatric patients with known or suspected IBD is still required.

This is a single-center, non-randomized open-label study intended to evaluate the safety and efficacy of the NaviAid™ AB device during small bowel enteroscopy in children with known or suspected IBD.

Enrollment: 50 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients between the ages 8-18
2. Patients with known or suspected IBD (including Crohn's disease or ulcerative colitis).
3. The patient/parent of patient must understand and provide written consent for the procedure.

Exclusion criteria

1. Subjects with known coagulation disorder;
2. Subjects with known hernia;
3. Subjects with suspected stricture or stenosis;
4. Any patient condition deemed too risky for the study by the investigator
5. Subjects who are currently enrolled in another clinical investigation.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

NaviAid™ AB

Experimental group

Description:

NaviAid™ AB device procedure

Treatment:

Device: NaviAid™ AB