Intestinal DiseasesNCT00398203
Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
A study testing NaviAid™ BGE Device in people with Intestinal Diseases, run by Smart Medical Systems Ltd. at 1 site in United Kingdom.
Trial summary
To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intestinal Diseases
- What is being tested?
- NaviAid™ BGE Device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to Jun 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/Female aged between 18-80 years (inclusive).
- Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
- Symptomatic subject defined as having at least one of the following signs or symptoms:
- Abdominal pain
- Cramps
- Bloating
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- Diarrhea
- Nausea
- Vomiting
- Unexplained Anemia
- GI bleeding from an unknown source
- Small bowel abnormality on any imaging study
- Subject able to comprehend and give informed consent for participation in this study
- Signed Informed Consent Form
Who cannot join
- Pregnancy
- Acute bowel obstruction
- Concomitant Coumadin or warfarin use
- Severe diverticulitis
- Recent (within the last 3 months) coronary ischemia or CVA (stroke)
- Any chronic unstable disease
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- Bleeding disorders
- Needing emergency surgery
- Any patient condition deemed too risky for SBE by the investigator
- Known cognitive or psychiatric disorder
- Physician objection
- Concurrent participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.
Read the detailed description
Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.
The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid™ BGE device in the examination of the small intestine in conjunction with a standard endoscope.
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure.
- Conditions
- Intestinal Diseases
- Being tested
- NaviAid™ BGE Device
- Keywords
- NaviAid™ BGE Device, Small Intestine, Intestinal Diseases
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviAid™ BGE DeviceDevice
Also called NaviAid™ Balloon Guided Endoscopy Device
NaviAid™ Balloon Guided Endoscopy Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization.
Measured: Within 6 months of completion of the trial
Secondary outcomes (1)
Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure.
Measured: Within 6 months of completion of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startFeb 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smart Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingvar Bjarnason, Prof., Principal investigator, Kings College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398203
- Sponsor's protocol ID
- CLI-10111
- Status last verified
- Jun 2012
- First submitted
- 8 Nov 2006
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using NaviAid™ BGE Device (Balloon Guided Endoscopy) For Endoscopic Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT00398203
- Acronym / sponsor ID
- CLI-10111
- Conditions
- Intestinal Diseases
- Keywords
- NaviAid™ BGE Device, Small Intestine, Intestinal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Smart Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Nov 2006 (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 assess the efficacy of the NaviAid™ BGE Device, while used in conjunction with a standard endoscope for the diagnosis and treatment of the small intestine.
Detailed description
Smart Medical Systems has developed the NaviAid™ Balloon Guided Endoscopy (BGE) Device, an innovative medical device for the GI tract diagnosis and treatment. The Balloon Guided Endoscopy (BGE) is a procedure intended for the examination of the small intestine, which utilizes the NaviAid™ BGE Device in conjunction with a standard endoscope.
The objectives of this prospective controlled study are to evaluate the safety and efficacy of using the NaviAid™ BGE device in the examination of the small intestine in conjunction with a standard endoscope.
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male/Female aged between 18-80 years (inclusive).
- Subject is scheduled for endoscopic procedure after the case was reviewed by one of the investigators.
- Symptomatic subject defined as having at least one of the following signs or symptoms:
- Subject able to comprehend and give informed consent for participation in this study
- Signed Informed Consent Form
Key exclusion criteria (12 listed)
- Pregnancy
- Acute bowel obstruction
- Concomitant Coumadin or warfarin use
- Severe diverticulitis
- Recent (within the last 3 months) coronary ischemia or CVA (stroke)
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™ BGE DeviceAlso: NaviAid™ Balloon Guided Endoscopy DeviceNaviAid™ Balloon Guided Endoscopy Device | Device | – |
Primary outcome
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization.
Time frame: Within 6 months of completion of the trial
1 secondary outcome
Safety of the NaviAid™ BGE Device will be assessed by reporting adverse events, and by comparing to a reference Enteroscopy procedure.
Time frame: Within 6 months of completion of the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
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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.
Ingvar Bjarnason, Prof. principal investigator
Kings College Hospital
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™ BGE Device in people with Intestinal Diseases, run by Smart Medical Systems Ltd. at 1 site in United Kingdom.
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 14 inclusion and 12 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: finished, as of the sponsor's last update on 12 Jun 2012. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy will be assessed by comparing NaviAid™ BGE Device performances to a reference Enteroscopy procedure in terms of depth of small intestine advancement and visualization. (time frame: Within 6 months of completion of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2012.