Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy
This study has been completed.
Information provided by (Responsible Party):
Yanqing Li, Shandong University
First received: January 4, 2010
Last updated: July 17, 2012
Last verified: July 2012
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.
Change of Image Quality of CLE
||Time Perspective: Prospective
||Evaluation of Image Quality Over Time After Injection of the ﬂuorescein Sodium for Confocal Laser Endomicroscopy
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
patients without any disease of heart,liver or kidney;patients without serious gastritis and other serious stomach lesions.
- 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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042171
|Department of Gastroenterology, Qilu Hospital, Shandong University
|Jinan, Shandong, China, 250012 |
||Yanqing Li, PhD. MD.
||Department of Gastroenterology, Qilu Hospital
No publications provided
ClinicalTrials.gov processed this record on December 09, 2013
||Yanqing Li, Chief of the Department of Gastroenterology, Qilu Hospital, Shandong University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2010
||July 17, 2012
||China: Ethics Committee