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Endoscopic Fluid Collection for Small Intestinal Conditions
N/A
Recruiting
Led By Ali Rezaie, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new way to collect small intestine fluid during endoscopy, which may be quicker and less prone to contamination than the current method.
Who is the study for?
This trial is for men and women aged 18-85 who are already scheduled to undergo an esophagogastroduodenoscopy, a type of endoscopic examination. There are no specific exclusion criteria since the procedure is being done for medical reasons unrelated to the study.
What is being tested?
The study tests a new capillary endoscopy aspiration catheter against the standard one during endoscopies at Cedars Sinai Medical Center. It aims to compare how well and quickly each catheter can collect fluid from the small intestine in two groups of 23 patients.
What are the potential side effects?
Since this trial involves using different types of catheters during a standard diagnostic procedure, there may not be additional side effects beyond those typically associated with an endoscopy, such as discomfort or minor bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The time(minutes) of the aspirate collection from small intestine will be measured in two groups
The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups
Secondary study objectives
The rate of adverse events such as perforation, and bleeding in two groups
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Capillary Aspiration Endoscopy Catheter groupExperimental Treatment1 Intervention
Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter
Group II: Aspiration endoscopy catheter groupActive Control1 Intervention
Small intestine aspirate suction was carried out with an aspiration endoscopy catheter
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Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
512 Previous Clinical Trials
163,318 Total Patients Enrolled
Ali Rezaie, MDPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 85 years old and scheduled for an EGD procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Capillary Aspiration Endoscopy Catheter group
- Group 2: Aspiration endoscopy catheter group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Microbiome Patient Testimony for trial: Trial Name: NCT04418258 — N/A
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