Capillary Endoscopy Aspiration Catheter

Overview

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.

Full Title of Study: “Evaluation of a Capillary Endoscopy Aspiration Catheter”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Health Services Research
  • Masking: None (Open Label)
• Study Primary Completion Date: June 1, 2024

Detailed Description

The Medically Associated Science and Technology (MAST) program at Cedars-Sinai is dedicated to the development of novel drugs and devices to diagnose and treat patients. This study designed to examine the efficiency of the aspiration capillary catheter during an endoscopy procedure. The investigators want to know if this capillary catheter can suction faster than the current commercially available endoscopic aspiration catheter. 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.

Interventions

• Device: 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
• Device: Endoscopy Aspiration Catheter
  • Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter[#2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy

Arms, Groups and Cohorts

• Experimental: Capillary Aspiration Endoscopy Catheter group
  • Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter
• Active Comparator: Aspiration endoscopy catheter group
  • Small intestine aspirate suction was carried out with an aspiration endoscopy catheter

Clinical Trial Outcome Measures

Primary Measures

• The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups
  • Time Frame: 5 minutes
  • The volume(millilitres) of the aspirate that collected from small intestine during upper endoscopy will be the primary end point
• The time(minutes) of the aspirate collection from small intestine will be measured in two groups
  • Time Frame: 5 minutes
  • The time(minutes) of the aspirate collection from small intestine will be measured in two groups

Secondary Measures

• The rate of adverse events such as perforation, and bleeding in two groups
  • Time Frame: 30 minutes
  • The rate of adverse events at 30 minutes after endoscopy

Participating in This Clinical Trial

Inclusion Criteria

• Male or female subjects aged 18-85 undergoing esophagogastroduodenoscopy. 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Cedars-Sinai Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: Ali Rezaie, MD, Medical Director of GI Motility Program – Cedars-Sinai Medical Center
• Overall Official(s)
  • Ali Rezaie, MD, Principal Investigator, Cedars-Sinai Medical Center
• Overall Contact(s)
  • MAST Program, (310) 423-0617, mastprogram@cshs.org