Clinical trial NCT02629211: Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
Official title: Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Keywords: Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Single-Balloon Enteroscopy
NaviAid AB™ Device
NaviAid AB™ Procedure
AB Device
Pediatric IBD
Pediatric Enteroscopy
Lead sponsor: Smart Medical Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of serious adverse events
timeFrame: Subjects will be followed up with in 72 hours following the procedure.
Secondary outcomes:
measure: Number of findings
timeFrame: Up to 14 days (histology)
measure: Procedural times
timeFrame: During procedure
measure: Depth of insertion
timeFrame: During procedure
measure: Ease of use
timeFrame: During procedure
measure: Classification of disease
timeFrame: Up to 14 days (histology)
measure: Extension of disease
timeFrame: Up to 14 days (histology)
Other outcomes:
Locations:
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Efrat Broide
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.