Capillary Endoscopy Aspiration Catheter

Evaluation of a Capillary Endoscopy Aspiration Catheter

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.

Study Overview

• Status: Recruiting
• Conditions: Microbiota; SIBO
• Intervention / Treatment: Device: Capillary Endoscopy Aspiration Catheter; Device: Endoscopy Aspiration Catheter

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.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MAST Program; Phone Number: (310) 423-0617; Email: mastprogram@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Mast Program; Phone Number: 310-423-7302; Email: mastprogram@cshs.org
      • Contact: Mast Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capillary Aspiration Endoscopy Catheter group; Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter	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
Active Comparator: Aspiration endoscopy catheter group; Small intestine aspirate suction was carried out with an aspiration endoscopy catheter	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Ali Rezaie, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Gut Microbiome; SIBO; Endoscopy aspiration Catheter
• Other Study ID Numbers: STUDY00000319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No