Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy (NCT01042171)

Study summary

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.

Conditions studied

Change of Image Quality of CLE

In context

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

patients without any disease of heart,liver or kidney;patients without serious gastritis and other serious stomach lesions.

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

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).

Study design

Time perspective: Prospective
Enrollment: 20 participants (actual)

What researchers measure

Primary outcomes

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

Study locations

1 site

Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong 250012, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01042171
Lead sponsor: Shandong University
Responsible party: Yanqing Li (Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University) — Principal investigator
First posted: Jan 5, 2010
Start date: Dec 2009
Primary completion: Jun 2010
Completion: Jun 2010
Last update: Jul 18, 2012

Study contacts

Yanqing Li, PhD. MD.

study director · Department of Gastroenterology, Qilu Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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