Skip to main content
OpenTrials
Completed

NCT Number: NCT01042171

Evaluation of Image Quality Over Time After Injection of the fluorescein Sodium for Confocal Laser Endomicroscopy

Confocal laser endomicroscopy (CLE) is a newly developed endoscopic technique. The most commonly used fluorescent substance is Fluorescein sodium.The plasma half-life of fluorescein is 11 minutes. A recent test estimated that fluorescein-based CLSM(confocal laser scanning microscopy) of the upper-GI tract of pigs delivers the best contrast and image quality within the first 8 minutes after injection of fluorescein .However, despite its increasing use in clinical examination,there are no data on contrast dynamics and image quality over time after injection of the fluorescein sodium in the inspection of gastrointestinal tract of human being.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Change of Image Quality of CLE

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • These subjects will include male or female aged between 18 and 60 years with indications for upper-endoscopy ,but without serious gastritis and other serious stomach lesions

Exclusion criteria

  • Complications such as gastric and/or duodenal peptic ulcer, stenosis
  • Esophageal, gastric or duodenal cancer or other malignancy
  • History of stomach surgery
  • A history of bronchial asthma, or known allergy to fluorescein.
  • Pregnant or breast-feeding (for females)
  • Below 18 or above 60 years of age
  • Severe comorbidities ( e.g. such as renal failure, congestive cardiac failure, liver cirrhosis).

Treatment and study plan

Primary outcomes

  1. The ideal time period for the best CLE imaging when using fluorescein sodium is about 10 minutes

    Time frame: Within the 30 minutes after injection of fluorescein

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 5, 2010
Registry last updated
Jul 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.