<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04418258</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000319</org_study_id>
    <nct_id>NCT04418258</nct_id>
  </id_info>
  <brief_title>Capillary Endoscopy Aspiration Catheter</brief_title>
  <official_title>Evaluation of a Capillary Endoscopy Aspiration Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The small intestine is an understudied frontier of microbiome research. While aspiration&#xD;
      during endoscopy is considered the gold standard to assess small bowel bacteria, the tools&#xD;
      for sterile retrieval are primitive and poorly validated.&#xD;
&#xD;
      Endoscopic aspiration is time-consuming and prone to contamination. Inspired by plants'&#xD;
      ability to draw water by capillary action, a novel multi-capillary sterile system was&#xD;
      designed which is a modified version of the conventional aspiration catheter.&#xD;
&#xD;
      The purpose of this study is to examine the time and volume capabilities of this catheter in&#xD;
      suctioning various liquids compared to conventional aspiration catheter, in two groups, each&#xD;
      includes 23 patients that going under endoscopy at GI lab at Cedars Sinai Medical Center. The&#xD;
      investigator will collect up to 2 ml fluid from Duodenum- in first group by using the&#xD;
      conventional catheter and in second group by using the capillary catheter. The time&#xD;
      collection and the volume of samples in 2 groups will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Medically Associated Science and Technology (MAST) program at Cedars-Sinai is dedicated&#xD;
      to the development of novel drugs and devices to diagnose and treat patients. This study&#xD;
      designed to examine the efficiency of the aspiration capillary catheter during an endoscopy&#xD;
      procedure. The investigators want to know if this capillary catheter can suction faster than&#xD;
      the current commercially available endoscopic aspiration catheter.&#xD;
&#xD;
      You are being asked to take part in this research study because you are undergoing an&#xD;
      endoscopy or esophagogastroduodenoscopy procedure as part of your clinical care.&#xD;
&#xD;
      The study will enroll up to 46 people in total. This research study is designed to test the&#xD;
      investigational use of a modified endoscopy aspiration catheter. The original, standard&#xD;
      endoscopy aspiration catheter has been approved by the U.S. Food and Drug Administration&#xD;
      (FDA), but the investigational catheter used in this study, which is similar in structure,&#xD;
      makeup, and function to this approved device, has not been approved by the FDA. During&#xD;
      regularly conducted endoscopy procedures, investigators will use either the standard catheter&#xD;
      or a different kind of catheter to collect up to 2 ml fluid from the small intestine. The&#xD;
      typical catheter used for this procedure is called an endoscopic aspiration catheter. The&#xD;
      modified catheter is a capillary aspiration catheter, which is constructed and functions a&#xD;
      bit differently. In the lab, this capillary aspiration catheter performs more efficiently,&#xD;
      meaning it collects the fluid faster and more successfully than the usual endoscopic&#xD;
      aspiration catheter. The investigators hope that using this different catheter will&#xD;
      demonstrate the same improved results when used in real situations in humans. The&#xD;
      investigators will record how long it takes to suction a sample of the intestinal contents (2&#xD;
      ml, approximately two-fifths of a teaspoon). These samples will be collected solely for&#xD;
      research purposes and will be discarded per standard after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups</measure>
    <time_frame>5 minutes</time_frame>
    <description>The volume(millilitres) of the aspirate that collected from small intestine during upper endoscopy will be the primary end point</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The time(minutes) of the aspirate collection from small intestine will be measured in two groups</measure>
    <time_frame>5 minutes</time_frame>
    <description>The time(minutes) of the aspirate collection from small intestine will be measured in two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of adverse events such as perforation, and bleeding in two groups</measure>
    <time_frame>30 minutes</time_frame>
    <description>The rate of adverse events at 30 minutes after endoscopy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Microbiota</condition>
  <condition>SIBO</condition>
  <arm_group>
    <arm_group_label>Capillary Aspiration Endoscopy Catheter group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aspiration endoscopy catheter group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Small intestine aspirate suction was carried out with an aspiration endoscopy catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Capillary Endoscopy Aspiration Catheter</intervention_name>
    <description>Small intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter[#CSL2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy</description>
    <arm_group_label>Capillary Aspiration Endoscopy Catheter group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopy Aspiration Catheter</intervention_name>
    <description>Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter[#2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy</description>
    <arm_group_label>Aspiration endoscopy catheter group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects aged 18-85 undergoing esophagogastroduodenoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no exclusion criteria for this study as subjects will be undergoing the&#xD;
             procedures for medical reasons and not for the purposes of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ali Rezaie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>MAST Program</last_name>
    <phone>(310) 423-0617</phone>
    <email>mastprogram@cshs.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mast Program</last_name>
      <phone>310-423-7302</phone>
      <email>mastprogram@cshs.org</email>
    </contact>
    <contact_backup>
      <last_name>Mast Program</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Ali Rezaie, MD</investigator_full_name>
    <investigator_title>Medical Director of GI Motility Program</investigator_title>
  </responsible_party>
  <keyword>Endoscopy aspiration Catheter</keyword>
  <keyword>SIBO</keyword>
  <keyword>Gut Microbiome</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418258
org study id: STUDY00000319
nct id: NCT04418258
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups
time frame: 5 minutes
description: The volume(millilitres) of the aspirate that collected from small intestine during upper endoscopy will be the primary end point
measure: The time(minutes) of the aspirate collection from small intestine will be measured in two groups
time frame: 5 minutes
description: The time(minutes) of the aspirate collection from small intestine will be measured in two groups
measure: The rate of adverse events such as perforation, and bleeding in two groups
time frame: 30 minutes
description: The rate of adverse events at 30 minutes after endoscopy
arm group label: Capillary Aspiration Endoscopy Catheter group
arm group type: Experimental
description: Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter
arm group label: Aspiration endoscopy catheter group
arm group type: Active Comparator
description: Small intestine aspirate suction was carried out with an aspiration endoscopy catheter
intervention type: Device
intervention name: Capillary Endoscopy Aspiration Catheter
description: Small intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter[#CSL2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy
arm group label: Capillary Aspiration Endoscopy Catheter group
intervention type: Device
intervention name: Endoscopy Aspiration Catheter
description: Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter[#2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy
arm group label: Aspiration endoscopy catheter group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ali Rezaie, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: MAST Program
phone: (310) 423-0617
email: mastprogram@cshs.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Ali Rezaie, MD
investigator title: Medical Director of GI Motility Program
sharing ipd: Undecided