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


Phase 0
18 Years
N/A
Not Enrolling
Both
Barrett's Esophagus

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

To determine whether tissue is neoplastic or non-neoplastic

Outcome Time Frame:

1 day

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

GCO # 08-1190

NCT ID:

NCT01384227

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Barrett's Esophagus
  • Barrett's esophagus
  • in vivo imaging
  • image guide microscope
  • Barrett Esophagus
  • Neoplasms

Name

Location

Mount Sinai Medical CenterNew York, New York  10029