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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02629211
• Other study ID #: AB 17701
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2015
• Last updated: August 21, 2016
• Start date: June 2016
• Est. completion date: February 2017

Study information

• Verified date: August 2016
• Source: Smart Medical Systems Ltd.
• Contact: Efrat Broide
• Phone: 08-9779722
• Email: efibroide[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer

Intervention

Device:
• NaviAid™ AB
NaviAid™ AB Procedure

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Tzrifin

Sponsors (1)

Lead Sponsor	Collaborator
Smart Medical Systems Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Number of findings	Histology results will be used to assess this outcome	Up to 14 days (histology)	No
Secondary	Procedural times		During procedure	No
Secondary	Depth of insertion		During procedure	No
Secondary	Ease of use	Ease of use will be scored using a scale of "Easy" Neutral" or "Difficult"	During procedure	No
Secondary	Classification of disease	Histology results will be used to assess this outcome	Up to 14 days (histology)	No
Secondary	Extension of disease	Histology results will be used to assess this outcome	Up to 14 days (histology)	No