Capillary Endoscopy Aspiration Catheter

NCT04418258 | Recruiting FDA Device

• 1 other identifier: STUDY00000319
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

SIBO; Microbiota

Keywords

Endoscopy aspiration Catheter; SIBO; Gut Microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The rate of adverse events such as perforation, and bleeding in two groups

  30 minutes

Study Arms (2)

Capillary Aspiration Endoscopy Catheter group

EXPERIMENTAL

Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter

Device: Capillary Endoscopy Aspiration Catheter

Aspiration endoscopy catheter group

ACTIVE COMPARATOR

Small intestine aspirate suction was carried out with an aspiration endoscopy catheter

Device: Endoscopy Aspiration Catheter

Interventions

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

Capillary Aspiration Endoscopy Catheter group

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

Aspiration endoscopy catheter group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Study Officials

• Ali Rezaie, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MAST Program

CONTACT

(310) 423-0617; mastprogram@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of GI Motility Program

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 5, 2020
• Study Start: May 20, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)