Recruiting

Capillary Endoscopy

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT04418258

Conditions

Microbiota

SIBO

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Capillary Endoscopy Aspiration Catheter

Endoscopy Aspiration Catheter

Study Details

Brief summary:

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.

Conditions

Microbiota

SIBO

Study ID

NCT04418258

Start date

May 20, 2020

Status verified date

Jan, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

46 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

Interventions

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

Endoscopy Aspiration Catheter

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

Primary outcome measure

  • The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups [ Time Frame: 5 minutes ]
  • The time(minutes) of the aspirate collection from small intestine will be measured in two groups [ Time Frame: 5 minutes ]

Central Contacts and Locations

Central contacts

MAST Program

(310) 423-0617mastprogram@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Mast Program

(310) 423-7302mastprogram@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Endoscopy aspiration Catheter
  • SIBO
  • Gut Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-01-26.