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

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

Detailed Description
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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.

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

Conditions
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Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease

Intervention / Treatment
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* Device: NaviAid™ AB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between the ages 8-18 Patients with known or suspected IBD (including Crohn's disease or ulcerative colitis). The patient/parent of patient must understand and provide written consent for the procedure. Exclusion Criteria: Subjects with known coagulation disorder; Subjects with known hernia; Subjects with suspected stricture or stenosis; Any patient condition deemed too risky for the study by the investigator Subjects who are currently enrolled in another clinical investigation.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaviAid™ AB<br>NaviAid™ AB device procedure | Device: NaviAid™ AB<br>* NaviAid™ AB Procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events | Patients will be followed up during the study period (3 hours) and once again 48-72 hours following the procedure. At both times, serious adverse events will be assessed. | Subjects will be followed up with in 72 hours following the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of findings | Histology results will be used to assess this outcome | Up to 14 days (histology) | 
| Procedural times |  | During procedure | 
| Depth of insertion |  | During procedure | 
| Ease of use | Ease of use will be scored using a scale of Easy Neutral or Difficult | During procedure | 
| Classification of disease | Histology results will be used to assess this outcome | Up to 14 days (histology) | 
| Extension of disease | Histology results will be used to assess this outcome | Up to 14 days (histology) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Single-Balloon Enteroscopy, NaviAid AB™ Device, NaviAid AB™ Procedure, AB Device, Pediatric IBD, Pediatric Enteroscopy