xml: <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/NCT05966311</url>
    </required_header>
    <id_info>
      <org_study_id>220001</org_study_id>
      <nct_id>NCT05966311</nct_id>
    </id_info>
    <brief_title>Pediatric Percutaneous Ultrasound Gastrostomy Technique</brief_title>
    <official_title>A Multi-center, Feasibility Study to Evaluate the Use and Safety and of the Pediatric PUMA-G System for Percutaneous Ultrasound Gastrostomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CoapTech</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Children's Hospital of Philadelphia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Children's National Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>CoapTech</source>
    <oversight_info>
      <has_dmc>Yes</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research study is to test a new device called the PUMA-G Pediatric&#xD;
        System. The research will measure if the device works well to safely aid doctors placing&#xD;
        gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational&#xD;
        device that uses ultrasound and magnets to guide insertion of a feeding tube.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the&#xD;
        performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) technique in the&#xD;
        pediatric population.&#xD;
  &#xD;
        A common method for placing gastrostomy tubes currently uses ionizing radiation to aid&#xD;
        doctors in procedural steps. Excess radiation usage may present long-term risks to pediatric&#xD;
        patients. The PUG procedure, using the PUMA-G Pediatric System, primarily uses ultrasound to&#xD;
        guide gastrostomy feeding tube placement.&#xD;
  &#xD;
        Up to 40 patients will be enrolled in the study and receive the PUG procedure using the&#xD;
        PUMA-G Pediatric System. Following the procedure, patients will be followed during their&#xD;
        hospital admission until discharge or up to 30 days. Data will be collected to assess how&#xD;
        safe the procedure was and if the procedure used less radiation. Study subjects will be&#xD;
        compared to a matched, retrospective cohort of patients who received standard of care&#xD;
        gastrostomy tube placement by Interventional Radiology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 7, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 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>
      <intervention_model_description>Participants prospectively enrolled are assigned to the interventional treatment procedure using the PUMA-G Peds System. A retrospective comparator is used as a means of comparing outcomes with a similar, historical cohort of patients who received the standard of care treatment procedure.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PUMA-G Pediatric System Device-Related Complication Rate</measure>
      <time_frame>up to 30 days</time_frame>
      <description>A composite rate of the quantity and severity of device related adverse events will be quantified (i.e. linking complications to what are caused by the device) in the post-procedural period including any additional medical/surgical interventions to resolve</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gastrostomy Procedure Complication Rate</measure>
      <time_frame>up to 30 days</time_frame>
      <description>The rate of other complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using standard of care Interventional Radiologic gastrostomy tube placement method</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)</measure>
      <time_frame>up to 30 days</time_frame>
      <description>The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by total fluoroscopic time (min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)</measure>
      <time_frame>up to 30 days</time_frame>
      <description>The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by dose area product (microGy-m2).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)</measure>
      <time_frame>up to 30 days</time_frame>
      <description>The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by skin dose (mGy).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications</measure>
      <time_frame>up to 30 days</time_frame>
      <description>The quantity of anesthesia/sedative medications used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medications and total procedural dosages will be quantified.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications</measure>
      <time_frame>up to 30 days</time_frame>
      <description>The quantity of antibiotic medications used during the PUG procedure and in the post-procedural timeframe will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medication and dosage will be measured.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Gastrostomy</condition>
    <condition>Gastrostomy Complications</condition>
    <condition>Pediatric Disorder</condition>
    <condition>Ultrasound</condition>
    <arm_group>
      <arm_group_label>Percutaneous Ultrasound Gastrostomy (PUG)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Percutaneous Radiologic Gastrostomy</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Percutaneous Ultrasound Gastrostomy</intervention_name>
      <description>Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System</description>
      <arm_group_label>Percutaneous Ultrasound Gastrostomy (PUG)</arm_group_label>
      <other_name>Ultrasound Gastrostomy</other_name>
      <other_name>PUG</other_name>
      <other_name>PUMA-G Pediatric Procedure</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Informed consent must be obtained from the patient or a Legally Authorized&#xD;
               Representative (ex. parent/guardian) before any study-specific assessment is performed&#xD;
  &#xD;
            -  Weight ≥10 (Phase 0, Phase 1, Phase 2)&#xD;
  &#xD;
            -  Weight ≥3kg and &lt;10kg (Phase 3)&#xD;
  &#xD;
            -  Estimated abdominal wall thickness ≤3cm&#xD;
  &#xD;
            -  Indication for gastrostomy tube placement determined to be present for any of the&#xD;
               following reasons:&#xD;
  &#xD;
            -  Anatomic: Ear, nose, or throat abnormalities (Pierre-Robin sequence cleft lip palate)&#xD;
  &#xD;
            -  Neurologic: Head trauma, Cerebral palsy&#xD;
  &#xD;
            -  Bowel Disease: Short Bowel syndrome, intestinal dysmotility, inflammatory bowel&#xD;
               disease, malabsorption&#xD;
  &#xD;
            -  Failure to Thrive: Cystic Fibrosis, Cholestasis, AID, Chronic renal failure, and food&#xD;
               refusal&#xD;
  &#xD;
            -  Patient determined to be an appropriate candidate for PUG, PEG, or PRG by the clinical&#xD;
               care team&#xD;
  &#xD;
            -  Anticipated discharge &gt; 24 hrs following gastrostomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Temperature ≥ 38 C&#xD;
  &#xD;
            -  Systolic BP &lt; 80 or &gt; 180 mmHg&#xD;
  &#xD;
            -  Heart Rate &lt; 50 or &gt; 160&#xD;
  &#xD;
            -  Estimated abdominal wall thickness &gt;3cm&#xD;
  &#xD;
            -  Coagulopathy defined by INR &gt; 1.7 or Platelets &lt;50,000&#xD;
  &#xD;
            -  Presence of a contraindication to being in proximity to a magnet (e.g. implantable&#xD;
               metallic device).&#xD;
  &#xD;
            -  History of prior gastrostomy, gastrectomy (partial or complete), or abdominal trauma&#xD;
               or upper-abdominal surgery.&#xD;
  &#xD;
            -  Scoliosis&#xD;
  &#xD;
            -  Atypical organ placement including microgastria&#xD;
  &#xD;
            -  Involvement in other investigational trials within 30 days prior to screening,&#xD;
  &#xD;
            -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
               female after conception and until the termination of gestation, confirmed by a&#xD;
               positive hCG laboratory test&#xD;
  &#xD;
            -  Patients with HgB &lt; 7g/dL, or fluid resuscitated within 48hrs prior, or received blood&#xD;
               transfusion within 48hrs prior, or active life threatening GI bleeding&#xD;
  &#xD;
            -  Esophageal Diseases: Atresia, stricture, caustic ingestion&#xD;
  &#xD;
            -  Spinal anomalies or atypical organ placement&#xD;
  &#xD;
            -  Any other medical condition(s) that may put the patient at risk or influence study&#xD;
               results in the investigator's opinion, based on the performance of a pre-procedural&#xD;
               assessment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jack Kent, MPH</last_name>
      <phone>4102151638</phone>
      <email>jack@coaptech.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Steven Tropello, MD</last_name>
      <phone>4348255184</phone>
      <email>steven@coaptech.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Children's National Hospital</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20010</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Bhupender Yadav, MD</last_name>
        <phone>202-476-4252</phone>
        <email>byadav@childrensnational.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nyph/Cumc</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10019</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Joshua Weintraub, MD</last_name>
        <phone>212-326-8874</phone>
        <email>jw750@cumc.columbia.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Children's Hospital Of Phildelphia</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anne Marie Cahill, MD</last_name>
        <phone>267-425-7118</phone>
        <email>CAHILL@chop.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gastrostomy</keyword>
    <keyword>Pediatric Gastrostomy</keyword>
    <keyword>Device Feasibility</keyword>
    <keyword>Device Safety</keyword>
    <keyword>Ultrasound</keyword>
    <keyword>POCUS</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966311
  org study id: 220001
  nct id: NCT05966311
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The purpose of this research study is to test a new device called the PUMA-G Pediatric
        System. The research will measure if the device works well to safely aid doctors placing
        gastrostomy feeding tubes in children. The PUMA-G Pediatric System is an investigational
        device that uses ultrasound and magnets to guide insertion of a feeding tube.
  This is a multi-center, non-randomized, non-blinded feasibility study to evaluate the
        performance and safety of the Percutaneous Ultrasound Gastrostomy (PUG) technique in the
        pediatric population.
  
        A common method for placing gastrostomy tubes currently uses ionizing radiation to aid
        doctors in procedural steps. Excess radiation usage may present long-term risks to pediatric
        patients. The PUG procedure, using the PUMA-G Pediatric System, primarily uses ultrasound to
        guide gastrostomy feeding tube placement.
  
        Up to 40 patients will be enrolled in the study and receive the PUG procedure using the
        PUMA-G Pediatric System. Following the procedure, patients will be followed during their
        hospital admission until discharge or up to 30 days. Data will be collected to assess how
        safe the procedure was and if the procedure used less radiation. Study subjects will be
        compared to a matched, retrospective cohort of patients who received standard of care
        gastrostomy tube placement by Interventional Radiology.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants prospectively enrolled are assigned to the interventional treatment procedure using the PUMA-G Peds System. A retrospective comparator is used as a means of comparing outcomes with a similar, historical cohort of patients who received the standard of care treatment procedure.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PUMA-G Pediatric System Device-Related Complication Rate
  time frame: up to 30 days
  description: A composite rate of the quantity and severity of device related adverse events will be quantified (i.e. linking complications to what are caused by the device) in the post-procedural period including any additional medical/surgical interventions to resolve
  measure: Gastrostomy Procedure Complication Rate
  time frame: up to 30 days
  description: The rate of other complications during the immediate procedural period between the PUG placement and a historical cohort of matched controls who underwent gastrostomy placement using standard of care Interventional Radiologic gastrostomy tube placement method
  measure: Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Fluoroscopic Time)
  time frame: up to 30 days
  description: The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by total fluoroscopic time (min).
  measure: Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Dose Area Product)
  time frame: up to 30 days
  description: The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by dose area product (microGy-m2).
  measure: Exposure to treatment conditions that pose long term risk to patient health: Ionizing Radiation (Skin Dose)
  time frame: up to 30 days
  description: The quantity of ionizing radiation used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Quantities of procedural ionizing radiation will be measured by skin dose (mGy).
  measure: Exposure to treatment conditions that pose long term risk to patient health: Anesthesia/Sedative Medications
  time frame: up to 30 days
  description: The quantity of anesthesia/sedative medications used during the PUG procedure will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medications and total procedural dosages will be quantified.
  measure: Exposure to treatment conditions that pose long term risk to patient health: Antibiotic Medications
  time frame: up to 30 days
  description: The quantity of antibiotic medications used during the PUG procedure and in the post-procedural timeframe will be compared to a historical cohort of matched controls who underwent gastrostomy placement using the standard of care Interventional Radiologic gastrostomy tube placement method. Medication and dosage will be measured.
  arm group label: Percutaneous Ultrasound Gastrostomy (PUG)
  arm group type: Experimental
  description: Enrolled subjects will receive the PUG procedure using the PUMA-G Pediatric System performed by an Interventional Radiologist
  arm group label: Percutaneous Radiologic Gastrostomy
  arm group type: No Intervention
  description: A matched, retrospective control cohort of patients previously admitted to hospital for the placement of gastrostomy tubes by Interventional Radiology will be used to compare performance of the PUMA-G Pediatric System to standard of care.
  intervention type: Device
  intervention name: Percutaneous Ultrasound Gastrostomy
  description: Ultrasound guided placement of gastrostomy tube using the PUMA-G Pediatric System
  arm group label: Percutaneous Ultrasound Gastrostomy (PUG)
  other name: Ultrasound Gastrostomy
  other name: PUG
  other name: PUMA-G Pediatric Procedure
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 21 Years
  healthy volunteers: No
  last name: Jack Kent, MPH
  phone: 4102151638
  email: jack@coaptech.com
  last name: Steven Tropello, MD
  phone: 4348255184
  email: steven@coaptech.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No