Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
1 other identifier
interventional
50
1 country
1
Brief Summary
To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
December 14, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 23, 2016
August 1, 2016
7 months
December 7, 2015
August 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Number of findings
Up to 14 days (histology)
Procedural times
During procedure
Depth of insertion
During procedure
Ease of use
During procedure
Classification of disease
Up to 14 days (histology)
- +1 more secondary outcomes
Study Arms (1)
NaviAid™ AB
EXPERIMENTALNaviAid™ AB device procedure
Interventions
Eligibility Criteria
You may qualify if:
- Patients between the ages 8-18
- Patients with known or suspected IBD (including Crohn's disease or ulcerative colitis).
- The patient/parent of patient must understand and provide written consent for the procedure.
You may not qualify if:
- Subjects with known coagulation disorder;
- Subjects with known hernia;
- Subjects with suspected stricture or stenosis;
- Any patient condition deemed too risky for the study by the investigator
- Subjects who are currently enrolled in another clinical investigation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofeh Medical Center
Tzrifin, Israel
Related Publications (1)
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.
PMID: 32187142DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Efrat Broide
Assaf-Harofeh Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2015
First Posted
December 14, 2015
Study Start
June 1, 2016
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
August 23, 2016
Record last verified: 2016-08