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NCT01384695 Clinical Trial

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

GERD Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01384695
Other study ID # GCO# 09-0696 Project 1
Secondary ID
Status Terminated
Phase Phase 0
First received June 28, 2011
Last updated January 8, 2016
Start date June 2009
Est. completion date February 2014

Study information
Verified date January 2016
Source Anandasabapathy, Sharmila, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 67
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Drug:
• Fluorescein
fluorescent contrast agent, Fluorescein 5ml
• Proflavine hemisulfate
3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)

Locations
Country Name City State
United States Mount Sinai Medical Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Anandasabapathy, Sharmila, M.D.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to determine whether tissue is neoplastic or non-neoplastic 1 day No
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