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Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.


N/A
18 Years
80 Years
Not Enrolling
Both
Barrett Esophagus

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Trial Information

Confocal Laserscanning Microscopy for Detection of Barretts Esophagus. A Blinded Multi-Center Study.


Inclusion Criteria:



- age between 18 and 80 years

- regular esophagogastroduodenoscopy for patients with known barrett esophagus (at
least stadium C0M1)

- patients presenting for endoscopic mucosectomy with intraepithelial neoplastic
changes <1cm

- patients presenting with suspected intraepithelial neoplastic changes

- patients receiving acid suppressive therapy in standard dose for at least 4 weeks

Exclusion Criteria:

- no informed consent

- thrombocytopenia, quick <50%, PTT >50 sec

- patients with coronary heart disease or existent valve plasties

- women with potential pregnancy

- patients with chronic renal failure

- patients with allergies

- patients with chronic obstructive pulmonary disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Outcome Measure:

diagnostic accuracy of confocal laser scanning microscopy for detection of metaplasia or neoplasia in Barrett´s esophagus

Principal Investigator

Alexander Meining, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Technical University Munich

Authority:

Germany: Ethics Commission

Study ID:

1129/04

NCT ID:

NCT00449995

Start Date:

March 2007

Completion Date:

November 2008

Related Keywords:

  • Barrett Esophagus
  • Barrett Esophagus

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