Inflammatory Bowel DiseasesNCT02629211
Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
A study testing NaviAid™ AB in people with Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Smart Medical Systems Ltd. at 1 site in Israel.
Trial summary
To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- What is being tested?
- NaviAid™ AB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Tzrifin
Efrat Broide, 08-9779722, efibroide@yahoo.com
About this study
To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.
Read the 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.
- Being tested
- NaviAid™ AB
- Keywords
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Single-Balloon Enteroscopy, NaviAid AB™ Device, NaviAid AB™ Procedure, AB Device, Pediatric IBD, Pediatric Enteroscopy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviAid™ ABDevice
NaviAid™ AB Procedure
| Study group | Role | What they receive |
|---|---|---|
| NaviAid™ AB | Experimental | NaviAid™ AB device procedure Receives: Device: NaviAid™ AB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects will be followed up with in 72 hours following the procedure.
Secondary outcomes (6)
Number of findings
Histology results will be used to assess this outcome
Measured: Up to 14 days (histology)
Procedural times
Measured: During procedure
Depth of insertion
Measured: During procedure
Ease of use
Ease of use will be scored using a scale of "Easy" Neutral" or "Difficult"
Measured: During procedure
Classification of disease
Histology results will be used to assess this outcome
Measured: Up to 14 days (histology)
Extension of disease
Histology results will be used to assess this outcome
Measured: Up to 14 days (histology)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startJun 2016
- Primary completionJan 2017 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smart Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Efrat Broide, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629211
- Sponsor's protocol ID
- AB 17701
- Status last verified
- Aug 2016
- First submitted
- 7 Dec 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32187142
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
- ClinicalTrials.gov ID
- NCT02629211
- Acronym / sponsor ID
- AB 17701
- Keywords
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Single-Balloon Enteroscopy, NaviAid AB™ Device, NaviAid AB™ Procedure, AB Device, Pediatric IBD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NaviAid™ AB | Experimental | Device: NaviAid™ ABNaviAid™ AB device procedure |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaviAid™ ABNaviAid™ AB Procedure | Device | NaviAid™ AB |
Primary outcome
Number of serious adverse events
Time frame: 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.
6 secondary outcomes
Number of findings
Time frame: Up to 14 days (histology)
Procedural times
Time frame: During procedure
Depth of insertion
Time frame: During procedure
Ease of use
Time frame: During procedure
Classification of disease
Time frame: Up to 14 days (histology)
Extension of disease
Time frame: Up to 14 days (histology)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Derived from this study: PubMed 32187142Broide 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Efrat Broide principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviAid™ AB in people with Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Smart Medical Systems Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efrat Broide (08-9779722, efibroide@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious adverse events (time frame: Subjects will be followed up with in 72 hours following the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.