ColonoscopyNBINCT00613262
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
A study testing Narrow Band Imaging in people with Colonoscopy and Adenomatous Polyp, run by Midwest Biomedical Research at 1 site in United States.
Trial summary
The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Adenomatous Polyp, Neoplastic
- What is being tested?
- Narrow Band Imaging
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- referral for screening or surveillance colonoscopy
- the ability to provide informed consent
Who cannot join
- prior surgical resection of any portion of colon
- prior history of colon cancer
- history of inflammatory bowel disease
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
- poor general condition or any other reason to avoid prolonged procedure time
- history of polyposis syndrome or Hereditary Non-polyposis colon cancer
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Amit Rastogi, MD, 816-861-4700 ext. 56725, amit.rastogi@va.gov
Amit Rastogi, MD
About this study
The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.
- Conditions
- Colonoscopy, Adenomatous Polyp, Neoplastic
- Being tested
- Narrow Band Imaging
- Keywords
- Narrow Band Imaging
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow Band ImagingOther
Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time
What is being measured
The primary outcome is the main question the study is designed to answer.
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startApr 2012
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Rastogi, Midwest Biomedical Research
- Investigators
- Amit Rastogi, MD, Principal investigator, Kansas City VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00613262
- Sponsor's protocol ID
- AR0002
- Other IDs
- 00371
- Acronym
- NBI
- Status last verified
- Feb 2009
- First submitted
- 31 Jan 2008
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging
- ClinicalTrials.gov ID
- NCT00613262
- Acronym / sponsor ID
- NBI / AR0002
- Conditions
- Colonoscopy, Adenomatous Polyp, Neoplastic
- Keywords
- Narrow Band Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 13 Feb 2008 (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.
The investigators hypothesize that NBI will have a high accuracy in predicting polyp histology real time during a colonoscopy by visualization of the surface mucosal and vascular patterns. Aim#1: To determine the sensitivity, specificity and accuracy of NBI and standard white light colonoscopy for predicting polyp histology by evaluating the surface mucosal and vascular patterns during colonoscopy. Aim#2: To determine the inter-observer agreement between investigators for the recognition of various polyp patterns.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referral for screening or surveillance colonoscopy
- the ability to provide informed consent
Key exclusion criteria (7 listed)
- prior surgical resection of any portion of colon
- prior history of colon cancer
- history of inflammatory bowel disease
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
- poor general condition or any other reason to avoid prolonged procedure time
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 |
|---|---|---|
| Narrow Band ImagingNarrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time | Other | – |
Primary outcome
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 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.
Amit Rastogi, MD principal investigator
Kansas City VA 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 Narrow Band Imaging in people with Colonoscopy and Adenomatous Polyp, run by Midwest Biomedical Research at 1 site in United States.
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 2 inclusion and 7 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 9 Apr 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 States. 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 Vikas Singh, MD, MHSA (816 861 4700 ext. 56428, vikas.singh@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome. (time frame: 1 year). 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 9 Apr 2012.