Evaluation of a Microendoscopic Imaging System in Examina... | NCT01968863

Studies
Evaluation of a Microendoscopic Imaging System in Examination of Resected Tissues

NCT01968863

Sponsor

University of Arkansas

Status

Terminated

Last Update Posted

Jul 10, 2015Estimated

Enrollment

13Actual

Phase

Not provided

Conditions

Known or Suspected Dysplasia or Cancer

Interventions

Not provided

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

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator Non Compliance

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Oct 15, 2013

First Submission Date that Met QC Criteria

Oct 18, 2013

First Posted Date

Oct 24, 2013Estimated

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

Jul 8, 2015

Last Update Posted Date

Jul 10, 2015Estimated

Name	Class
University of Arkansas, Fayetteville	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 overall objective of this exploratory, laboratory study is to evaluate whether noninvasive fluorescence microendoscopic imaging of tissue can assist clinicians in detecting dysplastic (precancerous) areas during standard surveillance. This is a study designed to evaluate the feasibility of using prototype imaging technology to enhance the detection of precancerous changes in various tissues. The results of this laboratory study will be used to further develop the technology for clinical application.

The primary aim of this project will be to investigate what digital image analysis criteria can be used to best detect dysplasia in various types of resected tissue.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Statistical measurements of the spatial and intensity distributions of pixels within an image	The statistical measurements will be used to correlate each microendoscope image to a histopathology diagnosis.	Up to 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females over the age of 18 scheduled for standard of care resection of abnormal tissue

Exclusion Criteria:

Previous chemotherapy or radiation treatment to the tissue to be resected
Inability to provide consent

Accepts Healthy Volunteers

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

Subjects with known or suspected dysplasia or cancer scheduled to undergo either endoscopic or surgical resection will be approached for participation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas for Medical Sciences		Little Rock	Arkansas	72205	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided