- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384227
Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study
January 8, 2016 updated by: Sharmila Anandasabapathy, MD, Anandasabapathy, Sharmila, M.D.
The overall objective of this study is to obtain data to evaluate whether high-resolution imaging of barrett's esophagus in vivo can assist clinicians in detecting dysplastic (precancerous) areas.
This is a pilot study of an novel technology, a miniaturized microscope device which can be used during upper endoscopy to image the gastrointestinal epithelium.
This is an exploratory, not a comparative, study designed to evaluate the feasibility of using this instrument in Barrett's esophagus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Barrett's without dysplasia
- Barrett's with dysplasia
- Esophageal Adenocarcinoma
Exclusion Criteria:
- Subjects unfit for standard upper endoscopy
- Subjects currently receiving chemo or radiation treatment
- Subject currently receiving PDT or ablation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proflavine Hemisulfate
|
Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether tissue is neoplastic or non-neoplastic
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sharmila Anandasabapathy, Mt. Sinai School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
June 21, 2011
First Submitted That Met QC Criteria
June 27, 2011
First Posted (Estimate)
June 29, 2011
Study Record Updates
Last Update Posted (Estimate)
January 12, 2016
Last Update Submitted That Met QC Criteria
January 8, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO # 08-1190
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Barrett's Esophagus
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Northwell HealthMayo Clinic; NinePoint MedicalCompletedBarrett's Esophagus Without Dysplasia | Barrett's Esophagus With Dysplasia | Barrett's Esophagus With Low Grade Dysplasia | Barrett's Esophagus With High Grade Dysplasia | Barrett's Esophagus With Dysplasia, UnspecifiedUnited States
-
Case Comprehensive Cancer CenterCompletedShort Segment Barrett's Esophagus | Long Segment Barrett's EsophagusUnited States
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The Guthrie ClinicActive, not recruiting
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Interscope, Inc.RecruitingBarrett's Esophagus With DysplasiaUnited States, Sweden, United Kingdom
-
Mayo ClinicCompletedBarrett's Esophagus With DysplasiaUnited States
-
Massachusetts General HospitalEnrolling by invitationBarrett Esophagus | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With DysplasiaUnited States
-
Lucid Diagnostics, Inc.CompletedBarrett Esophagus | Esophageal Adenocarcinoma | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With DysplasiaUnited States, Spain
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University of CambridgeUniversity of NottinghamRecruitingBarrett's OesophagusUnited Kingdom
-
Johns Hopkins UniversityAmerican Society for Gastrointestinal Endoscopy; Pentax Medical CorporationCompletedBarrett's Esophagus, Esophageal Intraepithelial NeoplasiaUnited States, Germany
-
Mayo ClinicFred Hutchinson Cancer CenterCompletedBarrett's Esophagus With High Grade Dsyplasia | Early Esophageal CancerUnited States
Clinical Trials on Proflavine Hemisulfate
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Anandasabapathy, Sharmila, M.D.William Marsh Rice UniversityCompletedSquamous Cell CancerUnited States
-
Anandasabapathy, Sharmila, M.D.William Marsh Rice UniversityCompletedBarrett's Esophagus | Intraepithelial NeoplasiaUnited States
-
Anandasabapathy, Sharmila, M.D.Baylor College of Medicine; William Marsh Rice UniversityUnknownBarrett's EsophagusUnited States
-
Anandasabapathy, Sharmila, M.D.TerminatedGERD | Barrett's EsophagusUnited States
-
Anandasabapathy, Sharmila, M.D.Baylor College of Medicine; William Marsh Rice UniversityUnknownSuspected or Known Squamous Cell Neoplasia | Prior History of Squamous Cell Dysplasia and /or NeoplasiaUnited States, China
-
Anandasabapathy, Sharmila, M.D.TerminatedColon Polyps | Anal Dysplasia | Colonic DysplasiaUnited States
-
M.D. Anderson Cancer CenterNational Institute of Dental and Craniofacial Research (NIDCR)Recruiting
-
Anandasabapathy, Sharmila, M.D.Baylor College of Medicine; University of Sao Paulo; William Marsh Rice UniversityCompletedSuspected or Known Squamous Cell Neoplasia | Prior History of Squamous Cell Dysplasia and /or NeoplasiaUnited States, Brazil
-
The University of Texas Medical Branch, GalvestonM.D. Anderson Cancer Center; The University of Texas Health Science Center,... and other collaboratorsActive, not recruitingMalignant Neoplasms of Female Genital OrgansUnited States
-
Sharmila Anandasabapathy, MDWilliam Marsh Rice UniversityTerminatedHead and Neck Cancer | Squamous Cell Carcinoma | NeoplasiaUnited States