<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/NCT03007511</url>
  </required_header>
  <id_info>
    <org_study_id>Fidmi</org_study_id>
    <nct_id>NCT03007511</nct_id>
  </id_info>
  <brief_title>Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device</brief_title>
  <acronym>Fidmi</acronym>
  <official_title>Safety and Usability Evaluation of the Fidmi Low-Profile Enteral Feeding Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fidmi Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fidmi Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device&#xD;
      on 20 adult patients with a need for enteral feeding. The primary outcome will be to evaluate&#xD;
      safety, usability and discomfort throughout the study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It&#xD;
      is a device frequently used in patients that have feeding difficulties or are unable to&#xD;
      maintain normal growth via oral feeds.&#xD;
&#xD;
      Currently there are many solutions in the market for long-term enteral feeding, however none&#xD;
      of them provide comfort and autonomy to their users, since they have a high probability of&#xD;
      dislodgement, clogging, leakage and are bulky.&#xD;
&#xD;
      The Fidmi Medical PEG Feeding Tube and Accessories are to provides food, liquids and&#xD;
      medications into the stomach of patients who are having difficulty of swallowing. Fidmi&#xD;
      Feeding Device is the first presented &quot;low-profile device from day 1&quot;, easily hidden under&#xD;
      clothing and not limiting mobility. Unlike other solutions, Fidmi device is resistant to&#xD;
      dislodgement due to a semi-rigid internal bumper, and avoids clogging thanks to a disposable&#xD;
      insert to deliver the nutrition.&#xD;
&#xD;
      Fidmi device consists of 1) a rigid-core silicone bumper that prevents dislodgment, 2) a&#xD;
      disposable internal tube replacement for a daily nutrition supply and prolonged patency, and&#xD;
      3) an external flexible bolster that keeps the stoma site ventilated and stable. The&#xD;
      disposable insert is placed inside the feeding port and is replaced every 1-2 weeks to avoid&#xD;
      clogging, extend the product life, and improve the cleanliness and hygiene of the tube.&#xD;
      Disposable tube replacement is easy and safe and can be done by the patients themselves or&#xD;
      their caregivers as the tract is never compromised and there is no need for a physician&#xD;
      verification. The device is eventually removed in a simple procedure that can be done by the&#xD;
      caregiver or patient themselves. Fidmi device obtain a tool that dismantles the internal&#xD;
      bumper into small parts that are naturally expelled from the body for trauma free-removal.&#xD;
&#xD;
      The Fidmi Feeding device would be inserted into eligible enrolled patients who would be&#xD;
      followed up during a period of 3 months until device removal. Safety, usability and&#xD;
      discomfort parameters would be monitored following 2, 30, 60, 90 and 120 days following the&#xD;
      insertion procedure.&#xD;
&#xD;
      In case a new Fidmi PEG device is requested by a patient: additional duration of 120 days±14&#xD;
      days will be added.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Due to limited financial resource&#xD;
  </why_stopped>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment related Adverse Events</measure>
    <time_frame>Through study completion, an average of 4 months</time_frame>
    <description>Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)</measure>
    <time_frame>at Day 0</time_frame>
    <description>Scored by the investigator performing the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)</measure>
    <time_frame>at 3 Months</time_frame>
    <description>Scored by the investigator performing the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accidental dislodgements</measure>
    <time_frame>until device removal at 3 months</time_frame>
    <description>Number of accidental dislodgements during study follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Pain</measure>
    <time_frame>at 3 months</time_frame>
    <description>Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Validate (True/False) correct (color) selection of 'Measuring Cannula' by residual tube measurement</measure>
    <time_frame>at day 0</time_frame>
    <description>design outcome</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Feeding Tube</condition>
  <condition>Dysphagia</condition>
  <arm_group>
    <arm_group_label>Fidmi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placement of Fidmi enhanced enteral feeding device; internal tubes replacement during follow up and device removal after 3 month from placement Fidmi enhanced enteral feeding device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fidmi enhanced enteral feeding device</intervention_name>
    <description>Fidmi enhanced enteral feeding device is intended to provide nutrition to a patient directly into the stomach through a stoma. The Fidmi PEG device would be investigated in this study on patients suffering from dysphagia, who are scheduled for PEG procedure in order to improve surgical initial insertion, device replacement and removal.</description>
    <arm_group_label>Fidmi</arm_group_label>
    <other_name>Low profile Gastrostomy</other_name>
    <other_name>Percutaneous Endoscopic Gastrostomy (PEG) device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patient 18 up to 90 years.&#xD;
&#xD;
          2. Consecutive adult patients suffering from dysphagia with need for enteral feeding&#xD;
             (PEG).&#xD;
&#xD;
          3. Ability to give informed consent for the study by patient or legal guardian.&#xD;
&#xD;
          4. Willingness to undergo 4 follow up visits 1, 3 and 4 months following PEG&#xD;
             insertion/replacement, as well as unscheduled sick visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy (all women of child-bearing age would be questioned and told by the&#xD;
             consenting physician regarding that criteria).&#xD;
&#xD;
          2. All current practice PEG contraindication&#xD;
&#xD;
          3. Acute gastrointestinal bleeding&#xD;
&#xD;
          4. Extreme obesity patients (BMI&gt;40)&#xD;
&#xD;
          5. Emergency endoscopy&#xD;
&#xD;
          6. Infectious disease local or systemic (e.g.- sepsis, pancreatitis)&#xD;
&#xD;
          7. Known esophageal pathology (e.g.- stenosis, eosinophilic esophagitis, varices,&#xD;
             achalasia)&#xD;
&#xD;
          8. In case of PEG replacement: lack of a well healed gastrostomy or Infection around the&#xD;
             insertion site.&#xD;
&#xD;
          9. Known gastric pathology that may prevent safe device insertion, feeding, removal and&#xD;
             Bumper flanges expulsion according to the investigator discretion.&#xD;
&#xD;
         10. Any history of bowel obstruction, pseudo-obstruction.&#xD;
&#xD;
         11. Crohn's disease&#xD;
&#xD;
         12. Recurrent vomiting&#xD;
&#xD;
         13. Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or&#xD;
             other contraindication to endoscopy&#xD;
&#xD;
         14. Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within 30 days of entry into this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacob Harold, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <state>Ein Kerem</state>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>http://trendlines.com/portfolio/fidmi/</url>
    <description>Fidmi Medical portfolio</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>February 6, 2022</last_update_submitted>
  <last_update_submitted_qc>February 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Percutaneous Endoscopic Gastrostomy</keyword>
  <keyword>Feeding tube</keyword>
  <keyword>Enteral nutrition</keyword>
  <keyword>Endoscopy</keyword>
  <keyword>Gastrointestinal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03007511/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03007511
org study id: Fidmi
nct id: NCT03007511
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A First In Human Usability Open Label trial will be performed using the Fidmi Feeding device
      on 20 adult patients with a need for enteral feeding. The primary outcome will be to evaluate
      safety, usability and discomfort throughout the study
A gastrostomy is a feeding tube that communicates from the skin directly into the stomach. It
      is a device frequently used in patients that have feeding difficulties or are unable to
      maintain normal growth via oral feeds.

      Currently there are many solutions in the market for long-term enteral feeding, however none
      of them provide comfort and autonomy to their users, since they have a high probability of
      dislodgement, clogging, leakage and are bulky.

      The Fidmi Medical PEG Feeding Tube and Accessories are to provides food, liquids and
      medications into the stomach of patients who are having difficulty of swallowing. Fidmi
      Feeding Device is the first presented "low-profile device from day 1", easily hidden under
      clothing and not limiting mobility. Unlike other solutions, Fidmi device is resistant to
      dislodgement due to a semi-rigid internal bumper, and avoids clogging thanks to a disposable
      insert to deliver the nutrition.

      Fidmi device consists of 1) a rigid-core silicone bumper that prevents dislodgment, 2) a
      disposable internal tube replacement for a daily nutrition supply and prolonged patency, and
      3) an external flexible bolster that keeps the stoma site ventilated and stable. The
      disposable insert is placed inside the feeding port and is replaced every 1-2 weeks to avoid
      clogging, extend the product life, and improve the cleanliness and hygiene of the tube.
      Disposable tube replacement is easy and safe and can be done by the patients themselves or
      their caregivers as the tract is never compromised and there is no need for a physician
      verification. The device is eventually removed in a simple procedure that can be done by the
      caregiver or patient themselves. Fidmi device obtain a tool that dismantles the internal
      bumper into small parts that are naturally expelled from the body for trauma free-removal.

      The Fidmi Feeding device would be inserted into eligible enrolled patients who would be
      followed up during a period of 3 months until device removal. Safety, usability and
      discomfort parameters would be monitored following 2, 30, 60, 90 and 120 days following the
      insertion procedure.

      In case a new Fidmi PEG device is requested by a patient: additional duration of 120 days±14
      days will be added.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Treatment related Adverse Events
time frame: Through study completion, an average of 4 months
description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
measure: Ease of the device placement procedure (using the 10-point Visual analogue scale satisfaction)
time frame: at Day 0
description: Scored by the investigator performing the procedure
measure: Ease of the device removal procedure (using the 10-point Visual analogue scale satisfaction)
time frame: at 3 Months
description: Scored by the investigator performing the procedure
measure: Accidental dislodgements
time frame: until device removal at 3 months
description: Number of accidental dislodgements during study follow up
measure: Patient Pain
time frame: at 3 months
description: Patient Pain on the Visual Analog Scale during device removal and sedative medication if administrated
measure: Validate (True/False) correct (color) selection of 'Measuring Cannula' by residual tube measurement
time frame: at day 0
description: design outcome
arm group label: Fidmi
arm group type: Experimental
description: Placement of Fidmi enhanced enteral feeding device; internal tubes replacement during follow up and device removal after 3 month from placement Fidmi enhanced enteral feeding device
intervention type: Device
intervention name: Fidmi enhanced enteral feeding device
description: Fidmi enhanced enteral feeding device is intended to provide nutrition to a patient directly into the stomach through a stoma. The Fidmi PEG device would be investigated in this study on patients suffering from dysphagia, who are scheduled for PEG procedure in order to improve surgical initial insertion, device replacement and removal.
arm group label: Fidmi
other name: Low profile Gastrostomy
other name: Percutaneous Endoscopic Gastrostomy (PEG) device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jacob Harold, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
facility: 
facility: 
country: Israel
url: http://trendlines.com/portfolio/fidmi/
description: Fidmi Medical portfolio
responsible party type: Sponsor
mesh term: Deglutition Disorders
sharing ipd: No
provided document: 