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

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

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative
• Intervention / Treatment: Device: NaviAid™ AB

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Efrat Broide; Phone Number: 08-9779722; Email: efibroide@yahoo.com

Study Locations

• Israel
  • Tzrifin, Israel
    • Recruiting
    • Assaf Harofeh Medical Center
    • Contact: Efrat Broide; Phone Number: 08-9779722; Email: efibroide@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NaviAid™ AB; NaviAid™ AB device procedure	Device: NaviAid™ AB; NaviAid™ AB Procedure

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Smart Medical Systems Ltd.
• Investigators: Principal Investigator: Efrat Broide, Assaf-Harofeh Medical Center

Publications and helpful links

General Publications

• Broide E, Shalem T, Richter V, Matalon S, Shirin H. The Safety and Feasibility of a New Through-the-scope Balloon-assisted Enteroscopy in Children. J Pediatr Gastroenterol Nutr. 2020 Jul;71(1):e6-e11. doi: 10.1097/MPG.0000000000002706.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 14, 2015

Study Record Updates

• Last Update Posted (Estimate): August 23, 2016
• Last Update Submitted That Met QC Criteria: August 21, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Crohn Disease; Inflammatory Bowel Diseases; Colitis, Ulcerative; Single-Balloon Enteroscopy; NaviAid AB™ Device; NaviAid AB™ Procedure; AB Device; Pediatric IBD; Pediatric Enteroscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: AB 17701