A Prospective, Single Blinded Study for Predicting Colon... | NCT00613262

Studies
A Prospective, Single Blinded Study for Predicting Colon Polyp Histology With Narrow Band Imaging

NCT00613262

Sponsor

Midwest Biomedical Research Foundation

Status

Unknown status

Last Update Posted

Apr 9, 2012Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Colonoscopy
Adenomatous Polyp
Neoplastic

Interventions

Narrow Band Imaging

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
00371

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Nov 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jan 31, 2008

First Submission Date that Met QC Criteria

Jan 31, 2008

First Posted Date

Feb 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2012

Last Update Posted Date

Apr 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amit Rastogi, Principal Investagator, Midwest Biomedical Research FoundationPrincipal Investigator

Lead Sponsor

Midwest Biomedical Research FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Narrow Band Imaging	Other	Narrow Band Imaging Colonoscope offers an alternative lightsource to view colon polyps in real time

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The mucosal and vascular patterns and their correlation with polyp histology will be used as the primary outcome.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

referral for screening or surveillance colonoscopy
the ability to provide informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vikas Singh, MD, MHSA	Contact	816 861 4700	56428	vikas.singh@va.gov

Overall Officials

Name	Affiliation	Role
Amit Rastogi, MD	Kansas City VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kansas City VA Medical Center	Recruiting	Kansas City	Missouri	64128	United States

Condition Browse Module

MeSH Terms

ID	Term
D018256	Adenomatous Polyps

Ancestor Terms

ID	Term
D000236	Adenoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062048	Narrow Band Imaging

Ancestor Terms

ID	Term
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided