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NCT04418258 · ClinicalTrials.gov registry record · NA
Capillary Endoscopy Aspiration Catheter
A NA study of Microbiota and SIBO, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04418258: Recruiting NA study of Microbiota and SIBO, sponsored by Cedars-Sinai Medical Center.
NCT04418258 is a NA study of Microbiota and SIBO that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 46 participants, below the 135-participant average among 10 other Microbiota trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04418258, a NA study of Microbiota and SIBO, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The volume(millilitres) of the aspirate that collected from small intestine during upper endoscopy will be the primary end point
Conditions Studied
Interventions
- DEVICE Capillary Endoscopy Aspiration Catheter
- DEVICE Endoscopy Aspiration Catheter
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-05-20 |
| Est. Completion | 2027-06-01 |
| Phase | NA |
What NCT04418258 shows while recruiting
NCT04418258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 135-participant average among 10 other Microbiota trials with a reported enrollment target (66% lower).
The record links to 2 conditions, with Microbiota appearing as the primary indexed condition, and to 2 interventions - of which Capillary Endoscopy Aspiration Catheter is the first listed.
NCT04418258 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04418258 about?
NCT04418258 is a clinical study titled "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 contamin...
What is the current status of trial NCT04418258?
This trial is currently recruiting. It is a NA study. The enrollment target is 46 participants. The study started on 2020-05-20. Estimated completion is 2027-06-01.
What conditions does trial NCT04418258 study?
This clinical trial studies the following conditions: Microbiota, SIBO.
What interventions are being tested in trial NCT04418258?
The interventions under investigation include: Capillary Endoscopy Aspiration Catheter (DEVICE), Endoscopy Aspiration Catheter (DEVICE).
Who is sponsoring clinical trial NCT04418258?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04418258 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04418258's enrollment target sits among peer trials
46 9th of 10 higher than 2 of 10 other Microbiota trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbiota trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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