Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
46 participants
INTERVENTIONAL
2020-05-20
2027-06-01
Brief Summary
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Endoscopic aspiration is time-consuming and prone to contamination. Inspired by plants' ability to draw water by capillary action, a novel multi-capillary sterile system was designed which is a modified version of the conventional aspiration catheter.
The purpose of this study is to examine the time and volume capabilities of this catheter in suctioning various liquids compared to conventional aspiration catheter, in two groups, each includes 23 patients that going under endoscopy at GI lab at Cedars Sinai Medical Center. The investigator will collect up to 2 ml fluid from Duodenum- in first group by using the conventional catheter and in second group by using the capillary catheter. The time collection and the volume of samples in 2 groups will be compared.
Detailed Description
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You are being asked to take part in this research study because you are undergoing an endoscopy or esophagogastroduodenoscopy procedure as part of your clinical care.
The study will enroll up to 46 people in total. This research study is designed to test the investigational use of a modified endoscopy aspiration catheter. The original, standard endoscopy aspiration catheter has been approved by the U.S. Food and Drug Administration (FDA), but the investigational catheter used in this study, which is similar in structure, makeup, and function to this approved device, has not been approved by the FDA. During regularly conducted endoscopy procedures, investigators will use either the standard catheter or a different kind of catheter to collect up to 2 ml fluid from the small intestine. The typical catheter used for this procedure is called an endoscopic aspiration catheter. The modified catheter is a capillary aspiration catheter, which is constructed and functions a bit differently. In the lab, this capillary aspiration catheter performs more efficiently, meaning it collects the fluid faster and more successfully than the usual endoscopic aspiration catheter. The investigators hope that using this different catheter will demonstrate the same improved results when used in real situations in humans. The investigators will record how long it takes to suction a sample of the intestinal contents (2 ml, approximately two-fifths of a teaspoon). These samples will be collected solely for research purposes and will be discarded per standard after the procedure.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Capillary Aspiration Endoscopy Catheter group
Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter
Capillary Endoscopy Aspiration Catheter
Small intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter\[#CSL2182; Hobbs Medical,Inc. Connecticut, US\] during upper endoscopy
Aspiration endoscopy catheter group
Small intestine aspirate suction was carried out with an aspiration endoscopy catheter
Endoscopy Aspiration Catheter
Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter\[#2182; Hobbs Medical,Inc. Connecticut, US\] during upper endoscopy
Interventions
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Capillary Endoscopy Aspiration Catheter
Small intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter\[#CSL2182; Hobbs Medical,Inc. Connecticut, US\] during upper endoscopy
Endoscopy Aspiration Catheter
Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter\[#2182; Hobbs Medical,Inc. Connecticut, US\] during upper endoscopy
Eligibility Criteria
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Inclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Ali Rezaie, MD
Medical Director of GI Motility Program
Principal Investigators
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Ali Rezaie, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Mast Program
Role: primary
Mast Program
Role: backup
Other Identifiers
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STUDY00000319
Identifier Type: -
Identifier Source: org_study_id