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

NCT ID: NCT01384695

Last Updated: 2016-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Conditions

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GERD Barrett's Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Fluorescein

Confocal imaging using contrast agent fluorescein

Group Type EXPERIMENTAL

Proflavine hemisulfate

Intervention Type DRUG

3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)

Proflavine hemisulfate

confocal imaging using contrast agent proflavine

Group Type EXPERIMENTAL

Fluorescein

Intervention Type DRUG

fluorescent contrast agent, Fluorescein 5ml

Interventions

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Fluorescein

fluorescent contrast agent, Fluorescein 5ml

Intervention Type DRUG

Proflavine hemisulfate

3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)

Intervention Type DRUG

Other Intervention Names

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Proflavine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anandasabapathy, Sharmila, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharmila Anandasabapathy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai School of Medicine

Locations

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Mount Sinai Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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GCO# 09-0696 Project 1

Identifier Type: -

Identifier Source: org_study_id

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