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

Not Applicable

• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Device: NaviAid™ AB

• Registration Number: NCT02629211
• Lead Sponsor: Smart Medical Systems Ltd.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-14
• Study Start: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-21
• Last Update Posted: 2016-08-23
• Primary Completion: 2017-01
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NaviAid™ AB	NaviAid™ AB	NaviAid™ AB device procedure

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events	Subjects will be followed up with in 72 hours following the procedure.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assaf Harofeh Medical Center; 🇮🇱 Tzrifin, Israel