MicrobiotaNCT04418258
Capillary Endoscopy Aspiration Catheter
A study testing Capillary Endoscopy Aspiration Catheter and Endoscopy Aspiration Catheter in people with Microbiota and SIBO, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Microbiota, SIBO
- What is being tested?
- Capillary Endoscopy Aspiration Catheter and Endoscopy Aspiration Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18-85 undergoing esophagogastroduodenoscopy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Mast Program, (310) 423-7302, mastprogram@cshs.org
Mast Program
About this study
Official title: Evaluation of a 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 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.
Read the detailed description
The Medically Associated Science and Technology (MAST) program at Cedars-Sinai is dedicated to the development of novel drugs and devices to diagnose and treat patients. This study designed to examine the efficiency of the aspiration capillary catheter during an endoscopy procedure. The investigators want to know if this capillary catheter can suction faster than the current commercially available endoscopic aspiration catheter.
You are being asked to take part in this research study because you are undergoing an endoscopy or esophagogastroduodenoscopy procedure as part of your clinical care.
The study will enroll up to 46 people in total. This research study is designed to test the investigational use of a modified endoscopy aspiration catheter. The original, standard endoscopy aspiration catheter has been approved by the U.S. Food and Drug Administration (FDA), but the investigational catheter used in this study, which is similar in structure, makeup, and function to this approved device, has not been approved by the FDA. During regularly conducted endoscopy procedures, investigators will use either the standard catheter or a different kind of catheter to collect up to 2 ml fluid from the small intestine. The typical catheter used for this procedure is called an endoscopic aspiration catheter. The modified catheter is a capillary aspiration catheter, which is constructed and functions a bit differently. In the lab, this capillary aspiration catheter performs more efficiently, meaning it collects the fluid faster and more successfully than the usual endoscopic aspiration catheter. The investigators hope that using this different catheter will demonstrate the same improved results when used in real situations in humans. The investigators will record how long it takes to suction a sample of the intestinal contents (2 ml, approximately two-fifths of a teaspoon). These samples will be collected solely for research purposes and will be discarded per standard after the procedure.
- Conditions
- Microbiota, SIBO
- Being tested
- Capillary Endoscopy Aspiration Catheter, Endoscopy Aspiration Catheter
- Keywords
- Endoscopy aspiration Catheter, SIBO, Gut Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary Endoscopy Aspiration CatheterDevice
Small intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter[#CSL2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy
Endoscopy Aspiration CatheterDevice
Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter[#2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Capillary Aspiration Endoscopy Catheter group | Experimental | Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter Receives: Device: Capillary Endoscopy Aspiration Catheter |
| Aspiration endoscopy catheter group | Active comparator | Small intestine aspirate suction was carried out with an aspiration endoscopy catheter Receives: Device: Endoscopy Aspiration Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 minutes
Secondary outcomes (1)
The rate of adverse events such as perforation, and bleeding in two groups
The rate of adverse events at 30 minutes after endoscopy
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start20 May 2020
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Rezaie, MD, Cedars-Sinai Medical Center
- Investigators
- Ali Rezaie, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418258
- Sponsor's protocol ID
- STUDY00000319
- Status last verified
- Jan 2026
- First submitted
- 28 May 2020
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Capillary Endoscopy Aspiration Catheter
- ClinicalTrials.gov ID
- NCT04418258
- Acronym / sponsor ID
- STUDY00000319
- Conditions
- Microbiota, SIBO
- Keywords
- Endoscopy aspiration Catheter, SIBO, Gut Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Medically Associated Science and Technology (MAST) program at Cedars-Sinai is dedicated to the development of novel drugs and devices to diagnose and treat patients. This study designed to examine the efficiency of the aspiration capillary catheter during an endoscopy procedure. The investigators want to know if this capillary catheter can suction faster than the current commercially available endoscopic aspiration catheter.
You are being asked to take part in this research study because you are undergoing an endoscopy or esophagogastroduodenoscopy procedure as part of your clinical care.
The study will enroll up to 46 people in total. This research study is designed to test the investigational use of a modified endoscopy aspiration catheter. The original, standard endoscopy aspiration catheter has been approved by the U.S. Food and Drug Administration (FDA), but the investigational catheter used in this study, which is similar in structure, makeup, and function to this approved device, has not been approved by the FDA. During regularly conducted endoscopy procedures, investigators will use either the standard catheter or a different kind of catheter to collect up to 2 ml fluid from the small intestine. The typical catheter used for this procedure is called an endoscopic aspiration catheter. The modified catheter is a capillary aspiration catheter, which is constructed and functions a bit differently. In the lab, this capillary aspiration catheter performs more efficiently, meaning it collects the fluid faster and more successfully than the usual endoscopic aspiration catheter. The investigators hope that using this different catheter will demonstrate the same improved results when used in real situations in humans. The investigators will record how long it takes to suction a sample of the intestinal contents (2 ml, approximately two-fifths of a teaspoon). These samples will be collected solely for research purposes and will be discarded per standard after the procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capillary Aspiration Endoscopy Catheter group | Experimental | Device: Capillary Endoscopy Aspiration CatheterSmall intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter |
| Aspiration endoscopy catheter group | Active comparator | Device: Endoscopy Aspiration CatheterSmall intestine aspirate suction was carried out with an aspiration endoscopy catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female subjects aged 18-85 undergoing esophagogastroduodenoscopy.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capillary Endoscopy Aspiration CatheterSmall intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter[#CSL2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy | Device | Capillary Aspiration Endoscopy Catheter group |
| Endoscopy Aspiration CatheterSmall intestinal fluid will be suctioned with using an endoscopy aspiration catheter[#2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy | Device | Aspiration endoscopy catheter group |
Primary outcome
The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups
Time frame: 5 minutes
The volume(millilitres) of the aspirate that collected from small intestine during upper endoscopy will be the primary end point
The time(minutes) of the aspirate collection from small intestine will be measured in two groups
Time frame: 5 minutes
The time(minutes) of the aspirate collection from small intestine will be measured in two groups
1 secondary outcome
The rate of adverse events such as perforation, and bleeding in two groups
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Rezaie, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capillary Endoscopy Aspiration Catheter and Endoscopy Aspiration Catheter in people with Microbiota and SIBO, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAST Program ((310) 423-0617, mastprogram@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups (time frame: 5 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.