Trial Summary
What is the purpose of this trial?The small intestine is an understudied frontier of microbiome research. While aspiration during endoscopy is considered the gold standard to assess small bowel bacteria, the tools for sterile retrieval are primitive and poorly validated.
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications since the study involves patients already undergoing a medical procedure.
Is endoscopic fluid collection for small intestinal conditions safe?
The safety data available is primarily for capsule endoscopy, which is generally safe but can have rare complications like capsule retention or aspiration into the lungs. These complications are infrequent, and with proper patient selection and monitoring, the risks can be minimized.
12345How does endoscopic fluid collection differ from other treatments for small intestinal conditions?
Endoscopic fluid collection is unique because it involves using capsule endoscopy, a non-invasive technique that allows for a complete exploration of the small intestine. This method is different from traditional treatments as it provides a safe and reliable way to diagnose and manage small intestinal conditions without the need for invasive procedures.
34678Eligibility Criteria
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.Inclusion Criteria
I am between 18 and 85 years old and scheduled for an EGD procedure.
Exclusion Criteria
There are no exclusion criteria for this study as subjects will be undergoing the procedures for medical reasons and not for the purposes of this study.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo endoscopy using either a standard or capillary aspiration catheter to collect fluid samples from the small intestine
1 day
1 visit (in-person)
Follow-up
Participants are monitored for adverse events such as perforation and bleeding after the endoscopy procedure
30 minutes
1 visit (in-person)
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cedars-Sinai Medical CenterLos Angeles, CA
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Who Is Running the Clinical Trial?
Cedars-Sinai Medical CenterLead Sponsor
References
Retention of small bowel capsule endoscopy. [2023]Capsule endoscopy is widely recognized as a safe and effective procedure to evaluate the small bowel and/or the colon noninvasively. Although infrequent, capsule retention is the most feared adverse event related to this technique. A better knowledge of risk factors, improvement of patients' selection and precapsule patency assessment may further contribute to reducing the incidence of capsule retention, even in patients at increased risk for this complication.
Incidence, clinical outcomes, and therapeutic approaches of capsule endoscopy-related adverse events in a large study population. [2022]Capsule endoscopy (CE) has become a first-line tool for small bowel (SB) examination. However, adverse events (AEs), such as CE retention or aspiration, may occur. The aims of this study were to evaluate incidence, clinical outcomes and therapeutic approaches of CE-related AEs in the largest series published to date.
A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. [2022]Capsule endoscopy (CE) is a powerful tool for evaluating the small bowel. Assessment of small-bowel cleansing for CE is an essential quality measure.
Capsule endoscopy. [2021]Capsule endoscopy (CE) is a simple, safe, non-invasive, reliable technique, well accepted and tolerated by the patients, which allows complete exploration of the small intestine. The advent of CE in 2000 has dramatically changed the diagnosis and management of many diseases of the small intestine, such as obscure gastrointestinal bleeding, Crohn's disease, small bowel tumors, polyposis syndromes, etc. CE has become the gold standard for the diagnosis of most diseases of the small bowel. Lately this technique has also been used for esophageal and colonic diseases.
Aspiration of capsule endoscope and successful bronchoscopic extraction. [2012]Capsule endoscopy is a novel tool for the diagnosis of small intestinal disorders. Recently, a new complication of the procedure in the form of the capsule's aspiration into the lungs has been reported. The aspiration of capsule endoscope can lead to a variety of complications including respiratory failure. A low threshold to suspect this complication and urgent bronchoscopic extraction in appropriate patients can prevent serious sequelae.
[Diagnostic utility of capsule endoscopy in occult gastrointestinal bleeding]. [2006]The video-capsule endoscopy (CE) of the small intestine is a novel innovative procedure for outpatient use that can detect even small lesions of the mucosa of the small intestine. Aim of this retrospective clinical study was to evaluate the diagnostic value of CE in a clinical routine setting.
Detection of abnormal lesions recorded by capsule endoscopy. A prospective study comparing endoscopist's and nurse's accuracy. [2022]Capsule endoscopy is a non-invasive technique for small bowel examination but its evaluation is time consuming. The aim of this study was to assess whether, following adequate training, an endoscopy nurse is capable of picking up all significant images without reducing the diagnostic accuracy of the procedure.
Current status and future perspectives of capsule endoscopy. [2020]Small bowel capsule endoscopy (CE) was first introduced 15 years ago, and a large amount of literature has since been produced, focused on its indication, diagnostic yields, and safety. Guidelines that have made CE the primary diagnostic tool for small bowel disease have been created. Since its initial use in the small bowel, CE has been used for the esophagus, stomach, and colon. The primary indications for small bowel CE are obscure gastrointestinal bleeding, unexplained iron deficiency anemia, suspected Crohn's disease, small bowel tumors, nonsteroidal anti-inflammatory drug enteropathy, portal hypertensive enteropathy, celiac disease, etc. Colon CE provides an alternative to conventional colonoscopy, with possible use in colorectal cancer screening. Guidelines for optimal bowel preparation of CE have been suggested. The main challenges in CE are the development of new devices with the ability to provide therapy, air inflation for better visualization of the small bowel, biopsy sampling systems attached to the capsule, and the possibility of guiding and moving the capsule by an external motion controller. We review the current status and future directions of CE, and address all aspects of clinical practice, including the role of CE and long-term clinical outcomes.