Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Conditions
Keywords
Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Single-Balloon Enteroscopy, NaviAid AB™ Device, NaviAid AB™ Procedure, AB Device, Pediatric IBD, Pediatric Enteroscopy
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.
Interventions
DEVICENaviAid™ AB
NaviAid™ AB Procedure
Sponsors
Smart Medical Systems Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Procedural times | During procedure | — |
| Depth of insertion | During procedure | — |
| Number of findings | Up to 14 days (histology) | Histology results will be used to assess this outcome |
| Classification of disease | Up to 14 days (histology) | Histology results will be used to assess this outcome |
| Extension of disease | Up to 14 days (histology) | Histology results will be used to assess this outcome |
| Ease of use | During procedure | Ease of use will be scored using a scale of Easy Neutral or Difficult |
Countries
Israel
Contacts
Primary ContactEfrat Broide
Outcome results
None listed