Capillary Endoscopy Aspiration Catheter

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT04418258
Status
Recruiting
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Conditions

  • Microbiota
  • SIBO

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
May 20, 2020
Status verified
Jan 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Mast Program
[email protected]
(310) 423-7302
Mast Program

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