A Feasibility Study of Confocal Microendoscopy in the Eva... | NCT01384695

Studies
A Feasibility Study of Confocal Microendoscopy in the Evaluation of Gastrointestinal Neoplasia -Project 1

NCT01384695

Sponsor

Anandasabapathy, Sharmila, M.D.

Status

Terminated

Last Update Posted

Jan 12, 2016Estimated

Enrollment

67Actual

Phase

Early Phase 1

Conditions

GERD
Barrett's Esophagus

Interventions

Fluorescein
Proflavine hemisulfate

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

Jan 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low/no enrollment. No subjects were enrolled over the past year.

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jun 28, 2011

First Submission Date that Met QC Criteria

Jun 28, 2011

First Posted Date

Jun 29, 2011Estimated

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

Jan 8, 2016

Last Update Posted Date

Jan 12, 2016Estimated

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 study is to obtain data to evaluate whether high-resolution imaging of the gastrointestinal mucosain vivo can assist clinicians in detecting dysplastic (precancerous) areas. This is an exploratory study of a confocal endoscope designed to evaluate the feasibility of using this FDA-approved device in the endoscopic surveillance of subjects at high-risk for neoplasia in the upper and lower GI tract. The confocal endoscope provides real-time in vivo microscopic images of the mucosa which resemble standard pathology.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluorescein	Experimental	Confocal imaging using contrast agent fluorescein	Drug: Proflavine hemisulfate
Proflavine hemisulfate	Experimental	confocal imaging using contrast agent proflavine	Drug: Fluorescein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluorescein	Drug	fluorescent contrast agent, Fluorescein 5ml	Proflavine hemisulfate

Measure	Description	Time Frame
to determine whether tissue is neoplastic or non-neoplastic		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient 18 years or older
colonoscopy for screening or surveillance of polyps or disease of colon
anoscopy because of suspected or known anal dysplasia or neoplasia

Exclusion Criteria:

patient unable to provide informed consent
patient found unfit for standard colonoscopy or anoscopy with biopsies

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sharmila Anandasabapathy, M.D.	Mt. Sinai School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai Medical Center		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D001471	Barrett Esophagus

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019793	Fluorescein
D011370	Proflavine

Ancestor Terms

ID	Term
D005452	Fluoresceins
D013141	Spiro Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided