Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

Early Phase 1

Completed

• Conditions: Barrett's Esophagus
• Interventions: Drug: Proflavine Hemisulfate

• Registration Number: NCT01384227
• Lead Sponsor: Anandasabapathy, Sharmila, M.D.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-29
• Primary Completion: 2011-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proflavine Hemisulfate	Proflavine Hemisulfate	-

Primary Outcome Measures

Name	Time	Method
To determine whether tissue is neoplastic or non-neoplastic	1 day

Trial Locations

Locations (1)

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States