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Clinical trial

Advanced Gastrointestinal Endoscopic Imaging

ID
Name
IRB-15766
Description
To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.
Trial arms
Trial start
2009-06-01
Estimated PCD
2024-12-01
Trial end
2025-12-01
Status
Recruiting
Treatment
Dual axis endoscopic microscope
This is a device that is used in the accessory port of a standard endoscope and allows visualization of microscopic areas of mucosa.
Arms:
endoscopy arm
Other names:
Stanford
wide field fluorescence system
This is a modification to the existing narrow band endoscope from Olympus that incorporates different filters on the source and collecting optics to enable fluorescence imaging. It is used as is a standard endoscope.
Arms:
endoscopy arm
Other names:
Olympus
CellVizio
Minimicroscope--this is an FDA approved fiber-based microscope that we will use according to the manufacturers protocols.
Arms:
endoscopy arm
Other names:
Mauna Kea Technologies
fluorescent Peptide
microdosing; Topical through the endoscope
Arms:
endoscopy arm
Other names:
GMP
fluorescein
100 mcg topical
Arms:
endoscopy arm
Other names:
fluorophore
indocyanine green
100 mcg topical
Arms:
endoscopy arm
Other names:
ICG
Size
500
Primary endpoint
Detection of neoplasia
5 years
Eligibility criteria
Inclusion Criteria:patients be at least 18 years of age, Either genders All ethnic backgrounds will be considered. Patients who are scheduled for endoscopy by one of the investigators will be asked if they are interested in participating in the study. The study will be open to all patients undergoing endoscopy that do not have exclusion criteria. We will ask all patients if they are participating in any other studies. If they are participating in any other study then we will ask them for more information to determine whether there could be any harm from participating in both studies and if there is then they will not be enrolled. Exclusion Criteria:Patients with unstable vital signs will not be included.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}
Updated at
2024-02-21

1 organization

3 products

3 indications

Organization
Stanford University
Product
Fluorescent Peptide
Indication
Gastrointestinal Diseases
Indication
Stomach cancer
Indication
Gastrointestinal Stromal Tumor
Product
fluorescein
Product
Indocyanine Green