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NCT Number: NCT04418258

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Mast Program

CONTACT

[email protected]

(310) 423-7302

Mast Program

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Capillary Endoscopy Aspiration Catheter

Device

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

Device

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

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

MAST Program

CONTACT

[email protected]

(310) 423-0617

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Evaluation of a Capillary Endoscopy Aspiration Catheter

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jun 5, 2020
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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