Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID04418258

Evaluation of a Capillary Endoscopy Aspiration Catheter

Led by Cedars-Sinai Medical Center · Updated on 2026-01-26

46

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating a new capillary endoscopy aspiration catheter designed to collect fluid from the small intestine more efficiently during an endoscopy procedure. The study focuses on comparing this novel catheter to the conventional endoscopy aspiration catheter in patients undergoing esophagogastroduodenoscopy. The goal is to measure the time and volume capabilities of the new catheter in suctioning intestinal fluid, addressing limitations of the current standard such as contamination and slow collection. Participants will be divided into two groups, each with 23 patients. One group will have fluid collected using the standard aspiration catheter, while the other will use the capillary aspiration catheter. Both devices are used during routine upper endoscopy to collect up to 2 milliliters of fluid from the duodenum. The study will compare the time taken and the volume of fluid collected by each catheter to evaluate performance. During the procedure, researchers will record how long it takes to suction the fluid and the volume collected. The samples will be used solely for research and discarded afterward. The study will also monitor for any adverse events like bleeding or perforation shortly after the procedure. Participation involves a single endoscopy visit with fluid collection lasting approximately 5 minutes, and safety monitoring for 30 minutes post-procedure. The total duration of involvement is limited to the clinical endoscopy appointment.

CONDITIONS

Brief Title

Capillary Endoscopy Aspiration Catheter

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects aged 18-85 undergoing esophagogastroduodenoscopy.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Implementation

Duration - 1 day

Participants undergo an endoscopy procedure during which small intestinal fluid is suctioned using either a capillary aspiration endoscopy catheter or a standard aspiration endoscopy catheter to compare their efficiency.

1 procedure visit (in-person)

Post-procedure Monitoring

Duration - 30 minutes

Participants are monitored for any adverse events such as perforation and bleeding following the endoscopy procedure.

1 post-procedure monitoring visit (in-person)

Trial Site Locations

Total: 1 location

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

M

MAST Program

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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